Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Esophageal Neoplasms

Skin Neoplasms

Stomach Neoplasms

Head and Neck Neoplasms

Hematologic Neoplasms

Breast Neoplasms

Lung Neoplasms

Urinary Bladder Neoplasms

Kidney Neoplasms

Uterine Neoplasms

Hematologic Diseases

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Stomach Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Kidney Diseases

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Esophageal Cancer

Stomach Cancer

Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice

Genomic testing

Richard Greil, MD

Thomas Winder, MD

Armin Gerger, MD

Andreas Seeber, MD

Martin Pecherstorfer, MD

Andreas Petzer, MD

Petra Pichler, MD

Klaus Wilthoner, MD

Sonja Heibl, MD

Christian Singer, MD

Edward Wöll, MD

There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

In the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages.

In particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed.

The registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in Austria and effect of molecular profiling on patient care and outcome.

Genomic Testing and Resulting Medical Decisions

The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification

To describe types of:molecular profiling methods used in the Austrian registry centres

To describe types of cancer, for which comprehensive molecular profiling is used

To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)

To describe targets identified:

* number of patients with at least one mutation identified
* number of patients with at least one druggable target identified
* number of patients with more than one druggable targets identified
* number of druggable targets per cancer type

To describe tests used and quality standards:

* to compare results of NGS based molecular test systems with single marker tests or small gene panel tests
* quality standards of the test methods used (TAT, certification status)
* to evaluate development of methods used over time
* usage of commercial testing vs. in-house testing, platforms used, and number of genes as well as gene size analyzed (eg whole exome with or without selected intron sequencing vs. hot spot exome sequencing)

To describe treatment decisions:

* frequency by which treatment decision follows the result of NGS testing
* frequency with druggable targets with available on-label therapy option
* treatment decisions in the presence of more than one druggable target

To describe outcome of treatment in patients receiving therapy in concordance with the test result

Roche Pharma AG

AstraZeneca

Arbeitsgemeinschaft medikamentoese Tumortherapie

Symptoms and General Pathology

Neoplasm Metastasis

Participants with head and neck squamous cell carcinoma who plan to undergo tumor resection and lymph node resection.

Participants with metastases to the brain from melanoma, lung cancer, breast cancer.

Head and Neck Cancer: PET imaging will be performed after initial diagnosis and within 2 weeks of MRI or CT of the neck done as standard of care. MRI will include T1 weighted pre and post gadolinium spin echo, diffusion weighted imaging, and T2 weighted imaging. CT of the head and neck with contrast will be performed per standard clinical protocol. Patients will get one intravenous line and one radial artery line placed prior to imaging and up to 5.5mCi (204MBq) of \[18F\] PDL192 tracer will be administered intravenously, as a bolus, once the patient is positioned on the scanner. 42 PET data will be acquired at single bed position and in list mode for 120 min after the start of tracer administration. Samples will be drawn from radial artery line.

adnectin 18F-BMS-986192 Head and Neck Cancer

Brain Metastases: Recruited patients will undergo standard clinical MRI within 2 weeks prior to PET, including T1 weighted pre- and post-gadolinium spin-echo and gradient-echo imaging, diffusion weighted imaging, susceptibility weighted imaging (2D SWI), T2 weighted imaging, 3D FLAIR, and combined DCE and dynamic susceptibility contrast (DSC) perfusion (DCE perfusion will be performed first, DSC perfusion will utilize T2 spin echo images). DCE perfusion will be processed on syngo Tissue 4D software (Siemens). DSC perfusion will be processed with syngo MR Perfusion Engine (Siemens). Patients will get one intravenous line and one radial artery line placed prior to imaging and up to 5.5mCi (204MBq) of \[18F\] PDL192 tracer will be administered intravenously, as a bolus, once the patient is positioned on the scanner. 42 PET data will be acquired at single bed position and in list mode for 120 min after the start of tracer administration. Samples will be drawn from radial artery line.

adnectin 18F-BMS-986192 Brain Metastases

Mariam S Aboian, MD PhD

This study aims to determine the feasibility of non-invasive quantitative PD-L1 measurement using \[a novel PD-L1 positron emission tomography (PET) tracer and perform immunohistochemistry based measurement of PD-L1 levels within resected lesions in head and neck cancer and brain metastases.

This study aims to validate a non-invasive quantitative imaging method of whole tumors using a novel PD-L1 positron emission tomography (PET) tracer in patients with head and neck cancer who undergo resection of primary tumor and locoregional lymph node metastases thus providing an excellent model to perform correlative studies with immunohistochemistry (IHC).

The investigators will extend the study to patients with brain metastases because there is a critical need for a non-invasive test for PD-L1 in this population, as biopsy of these lesions is rare.

In this study, the investigators will image patients with brain metastases, which are predominantly from lung cancer and melanoma, that are planned to undergo biopsy. The ultimate goal of this research is to validate quantitative PD-L1 PET imaging in determining PD-L1 expression within primary and metastatic cancer without the need for biopsy and identify parameters of PD-L1 quantitative PET that will allow its translation into clinical practice. This method can then be used to determine which patients may benefit from immunotherapy.

The primary objective of this study aims to test the difference in non-invasive quantitative PD-L1 PET measures (VT) of lesions between different groups of PD-L1 levels (PD-L1 ≥90% vs \<1%) in head and neck cancer primary lesions.

Secondary objectives:

1. To establish lesion level association between immunohistochemistry measures of PD-L1 levels within primary head and neck cancer lesions (as the outcome) and PD-L1 PET measures (VT);
2. To establish lesion level association between immunohistochemistry measures of PD-L1 levels within locoregional metastases within the neck and resected normal lymph nodes (as the outcome) and PD-L1 PET measures (VT).
3. To establish lesion level association between the degree of tumor inflammatory cell infiltration on IHC in primary head and neck squamous cell carcinoma (SCC) lesions (as the outcome) and PD-L1 PET measures (VT);
4. To establish lesion level association between the degree of tumor inflammatory cell infiltration on IHC in metastatic head and neck SCC lesion (as the outcomes) and PD-L1 PET measures (VT).

Tertiary objective:

To establish lesion level correlation of IHC measures of total/tumor/inflammatory cell PD-L1 levels to PD-L1 (VT) on PET in brain metastases

Patients with head and neck squamous cell carcinoma who plan to undergo tumor resection and lymph node resection (Aim1). Patients with metastases to the brain from melanoma, lung cancer, breast cancer (Aim 2).12 patients with head and neck cancer will be recruited for Aim 1. 12 patients with brain metastases will be recruited for Aim 2.

Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases

Pilot Study of Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases

To establish lesion level correlation of IHC measures of total/tumor/inflammatory cell PD-L1 levels compared to PD-L1 (VT) on PET in brain metastases using Pearson correlation between pathology based measure and imaging based measure.

To test the difference in non-invasive quantitative PD-L1 PET measures (VT) of lesions between different groups of PD-L1 levels (PD-L1 ≥90% vs \<1%) in head and neck cancer primary lesions

To establish lesion level association comparing immunohistochemistry measures of PD-L1 levels within primary head and neck cancer lesions and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure.

To establish lesion level association comparing immunohistochemistry measures of PD-L1 levels within locoregional metastases within the neck and resected normal lymph nodes (as the outcome) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure.

To establish lesion level association comparing the degree of tumor inflammatory cell infiltration seen on IHC in primary head and neck SCC lesions (as the outcome) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure.

To establish lesion level association comparing the degree of tumor inflammatory cell infiltration on IHC in metastatic head and neck SCC lesion (as the outcomes) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure.

National Cancer Institute (NCI)

Yale University

Associate Professor of Radiology

Wounds and Injuries

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Lidocaine

Morphine

Analgesics, Opioid

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Narcotics

For the preparation of the gel formulated for the intervention, the proportion of an ampoule of dimorf® (morphine sulfate) in the injectable presentation of 10mg/ml will be used. Morphine sulfate is a strong, systemic opioid analgesic used for the relief of severe pain.

For the base of the compound, Curatec Hidrogel with Alginate® will be used. A transparent and viscous hydrogel, which provides a moist environment, preventing the dressing from adhering to the skin, preventing additional injuries generated by difficulty removing the dressing.

Morphine Sulfate

The control group will receive lidocaine® in gel (2% sterile jelly lidocaine hydrochloride) alone. Because it is a homogeneous, transparent gel, free of lumps and impurities, it has similar characteristics to the hydrogel (Curatec Hidrogel with Alginate®) used in the preparation of morphine gel, guaranteeing the blinding of the study.

Lidocaine Hcl 2% Jelly

Daianny A de Oliveira da Cunha, MSc.

The goal of this clinical trial is to compare in compare pain reduction in patients with malignant wounds using morphine gel or lidocaine gel. The main question to be answered is:

• Does morphine gel offer better pain control in malignant wounds when compared to lidocaine gel? Participants will answer a questionnaire where they report a note for pain at the site of the malignant wound and then the dressing will be performed by a nurse from the research team. The patient and the nurse do not know which product is being used. At the end of the dressing, the patient answers a new questionnaire. This process will be carried out for 3 days.

The researchers will compare the intervention group (morphine gel) and the control group (lidocaine gel) and verify if there is a difference in pain reduction between the two products.

Potential participants will be all patients with malignant wounds in the head and neck or breast region who meet the inclusion and exclusion criteria, forming the study population.

After signing the free and informed consent form, the intervention group will receive topical morphine based on hydrogel in the formulation of 10mg of morphine sulfate - intravenous solution (1 ml) with 8g of hydrogel and the control group will receive lidocaine in gel.

To ensure the quality and accuracy of the data, in addition to the safety of the research participants, face-to-face monitoring visits will be carried out by the team from the Representative Area of Clinical Research (ARPC)/INCA throughout the execution of this protocol.

After signing the TCLE by the patient and researcher, the completion of the clinical form will begin. The pharmacist of the research team responsible for the randomization will be contacted to inform the inclusion of the patient in the study. The research team doctor will be responsible for prescribing the medication to be used, be it morphine or lidocaine gel, with a view to release by the hospital pharmacy.

Both morphine gel and lidocaine gel will be prepared in a flow hood suitable for handling the medications.

Adverse events will be reported, using medical terminology, in the source document and in the eCRF (electronic case report form). Upon identification of a reaction, the participant will be evaluated by the research team physician. All measures required for the treatment of the adverse event will be recorded in the source document.

Randomization and allocation will be performed using Research Electronic Data Capture (REDCap) software in a form that will only be viewed by non-blind members of the pharmacy team, responsible for handling the products and sending them to the team nurse who will be responsible for wound dressing evil.

The data collection forms (eCRF) will be customized in the REDCap software by the representative research area (ARPC) data management team. The data will be entered into the eCRFs according to the standard operating procedures of the Division of Clinical Research-INCA. The data will be exported to the R software by API (Application Programming Interface) where the statistical analyzes will be performed.

The sample size of each group was determined using the G\*Power application (version 3.1.9.4), using the Wilcoxon and Mann-Whitney nonparametric test approach. The calculation suggests a minimum sample size of 53 patients per group.

In the first part of the analysis, a descriptive analysis of the sample profile and comparison of the baseline variables of the control and intervention groups will be performed. The second part will evaluate the effect of the treatments in the control and intervention groups, analyzing the significance of the observed differences and the size of the treatment effect.

For qualitative variables, the significance of the association between two variables, or the difference between the distribution of the proportions of the two groups, will be investigated using the chi-square test and, when it proves to be inconclusive, Fisher's exact test will be used.

The odds ratio (OR) will be the measure used to express some risk of a qualitative outcome when comparing the occurrence of the outcome in the groups.

For quantitative variables, the normality of distributions will be verified by the Kolmogorov-Smirnov and Shapiro-Wilk tests. If the variable of interest has a normal distribution in both groups, the comparison will be made using the student's t-test; if at least one of the groups does not present normal distribution, or if the variable to be compared is an ordinal scale, such as the pain scale, the comparison of the two groups will be performed using the Mann-Whitney test.

Two repeated measures in different evaluations will be compared by the paired Student's t-test, if the two measures present normal distribution, or by the Wilcoxon signed rank test, if at least one of the measures does not present normal distribution or if it is a scale measure ordinal.

More than two repeated measures will be compared by ANOVA for repeated measures, in the case of normality for all measures, or by the Friedman test, if at least one of the measures does not present normal distribution, or if it is an ordinal scale measure.

Classifications or qualitative factors observed repeatedly at different times will be compared by McNemmar test.

The effect of the received intervention on the pain score will be evaluated by the Glass effect size measure.

Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds

Effectiveness of Topical Morphine Use in Patients With Painful Neoplastic Wounds in the Breast and Head and Neck: Double Blind Randomized Clinical Trial - MorphineGEL

The scale assesses the intensity of pain, where 0 means no pain and 10 means the most intense pain possible

Difference in the means of pain assessed by the numeric pain assessment scale before and after the intervention.

General comfort questionnaire with scores ranging from 48-192, where 48 reports the worst comfort measure and 192 the highest comfort level reported by the patient.

Instituto Nacional de Cancer, Brazil

Principal Investigator

Liver Neoplasms

Liver Diseases

Hematinics

Liver Extracts

A 3-to-6-week prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.

The prehabilitation program consists of 4 components:

1. Fitness training led by a physiotherapist. The patients will receive personalized training schedules to perform at home. The training sessions focus on improving aerobic fitness (biking or walking) and muscle strength (specific exercises for the different patient groups) and respiratory exercises aimed to relax.
2. Nutritional counseling led by a dietician. All patients will be offered an intake with a dietician (60 min) to discuss current eating habits and give personalized advices. Based on indication, patients will receive follow-up consults.
3. Smoking cessation counseling led by a trained social worker. For patients that are currently smoking, a social worker will offer counseling sessions to coach the patient in the process of smoking cessation.
4. Psychosocial counseling led by a psychologist. All patients will be offered counselling by a psychologist.

Prehabilitation

Nienke ter Hoeve, PhD

The objective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with head and neck cancer or liver cancer. Participating patients will participate in a 3-to-6 week rehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.

In patients diagnosed with head and neck cancer (HNC) or liver cancer, (major) surgery is the standard of care. Nevertheless, surgery may result in complications that have a substantial impact on the physical and psychological state of the patient. Detrimental postoperative outcomes are influenced by unhealthy lifestyle behaviors such as a sedentary lifestyle, smoking and malnutrition. Prehabilitation programs focusing on these lifestyle aspects have been suggested as a promising intervention to improve pre- and postoperative outcomes. Therefore, the obective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with HNC or liver cancer

This study concerns a prospective cohort study in 60 patients with HNC or liver cancer that participate in a 3 to 6-week pilot prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.

Data on feasibility (program satisfaction, program compliance and percentage of patients willing to participate in the prehabilitation program) and effectiveness (e.g. complications, health status, compliance to healthy lifestyle) is collected at three time points (pre- and post the prehabilitation program and 30 days post-surgery).

PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)

Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)

Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.

It will be registered which patient are willing and not willing to participate

Groningen Frailty Score questionnaire score: score of 0-15, a GFI score of four or greater is considered the cut-off point for frailty

6-minute walk test: meters walked in 6 minutes time

ActiGraph GTx3+ accelerometer: average time per day (min) spend in moderate-to-vigorous activity, light physical activity and sedentary behaviour

Biodex dynamometer (Peak torque to body weight extension + Work fatigue)

Short Nutritional Assessment Questionnaire (SNAQ) score (range 4-20, lower score means higher risk of malnutrition)

EuroQol-5D (EQ5D) questionnaire score (0-1, the maximum score of 1 indicates the best health state)

Hospital Anxiety and Depression Scale questionnaire score (0-21, higher scores denotes risk of anxiety or depression

General Self Efficacy Scale questionnaire score (10-40, with a higher score indicating more self-efficacy

Self-designed questionnaire (smoking yes/no)

carbon monoxide breath analyser (CO ppm + % COhb)

Five shot questionnaire score (0-7, a higher score indicates possible alcohol misuse)

Registrered in patient file (length in days)

Registrered in patient file (number of complications and clavien dindo grade)

Number and reason for readmissions in first 30 days

Single-item question (high, middle, low educated)

Single-item question (Partnered/ unpartnered)

Single-item question (employed/unemployed)

Rijndam Revalidatiecentrum

Capri Hartrevalidatie

Erasmus Medical Center

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Nicole Kelleners-Smeets, dr.

This study examines tumor- en surgical characteristics of stage T3 cutaneous squamous cell carcinomas on the scalp, diagnosed between 2010 and 2018. Histological data and patient- and tumor characteristics were collected.

Cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer, following basal cell carcinoma. Following the American Joint Committee on Cancer Tumour, Node and Metastasis (TNM) Classification of Malignant Tumors staging system (TNM8), T3 cutaneous squamous cell carcinomas comprise an interesting group, especially on the scalp, because of the thin subcutaneous fat layer. According to the TNM8 criteria, T3 include all cutaneous squamous cel carcinomas with greatest tumor dimension ≥4cm, tumors with minimal bone erosion or perineural growth (defined as involvement of the nerve sheath of a nerve lying deeper than the dermis or measuring 0.1mm or larger in caliber or showing clinical or radiographic involvement of nerves without invasion of the skull base) or with deep invasion. Deep invasion is defined as invasion deeper than the subcutaneous fat or a tumor thickness \>6mm. The scalp has a natural anatomical and oncological barrier for extension in depth known as the epicranial aponeurosis, also called the galea aponeurotica.

This retrospective study, examines the tumor- en surgical characteristics of these stage T3 cutaneous squamous cell carcinomas on the scalp.

Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp

Choice of treatment, complications, reconstruction types

Histological data on invasion depth, tumor differentiation

Maastricht University Medical Center

Patients randomized to the SOC treatment planning arm will receive a treatment planning computed tomography (CT) scan followed by dosimetric planning with a medical dosimetrist; and the plan will be reviewed by a medical physicist and radiation oncologist. This is the current standard practice for all radiation oncology patients.

Patients randomized to the MLAP arm will receive a treatment planning scan followed by MLAP through the RapidPlan module produced by Varian. Of note, RapidPlan is an FDA cleared module with treatment planning being the approved usage for the program. The RapidPlan module has site specific treatment packages for different disease sites. These separate disease specific packages have different capabilities. For example, the Head and Neck package currently audits dosimetrist-generated plans for possible improvements. The MLAP arm of the trial will leverage the RapidPlan module's full capabilities upwards to the FDA-approved usage.

Radiation therapy simulation, target delineation, dosing, localization, and follow-up will be followed per standard of care practices and/or at the discretion of the treating radiation oncologist. To elaborate, patients will receive a treatment planning CT (computed tomography) scan, followed by normal tissue delineation through the physician and/or medical dosimetry assistant, followed by target delineation by the physician, followed by radiation treatment planning with the dosimetrist and medical physicist. The preliminary plan will be run through the RapidPlan module, which will give a list of possible improvements to the plan. The dosimetrist will then make an amendment to the plan according to RapidPlan suggestions, followed by plan change requests and approval by the physician.

Machine Learning Assisted Radiation (MLAP) RapidPlan

Radiation therapy simulation, target delineation, dosing, localization, and follow-up will be followed per standard of care practices and/or at the discretion of the treating radiation oncologist. To elaborate, patients will receive a treatment planning CT (computed tomography) scan, followed by normal tissue delineation through the physician and/or medical dosimetry assistant, followed by target delineation by the physician, followed by radiation treatment planning with the dosimetrist and medical physicist, followed by plan change requests and approval by the physician.

Radiation Therapy Standard of Care (SOC)

Clinical Trials Referral Office

Christy Todd

Shawn Haren

Samir H. Patel, M.D.

Caroline Pamboukas

Byron C. May, M.D.

Timothy F. Kozelsky, M.D.

Ron S. Smith, M.D.

Zachary C. Wilson, M.D.

Abigail L. Stockham, M.D.

Daniel J. Ma, M.D.

The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.

This is a randomized phase III trial to evaluate the effectiveness of MLAP compared to Standard of Care. Patients will undergo a randomization procedure with a variable allocation ratio where the first third of patients are randomized 3:1 in favor of SOC, the next third randomized 1:1, and the last third randomized 1:3 in favor of MLAP. This is done to give dosimetrists time to optimize the MLAP workflow. Since the treatment team may learn to improve their treatment planning process in the SOC arm through interactions with RapidPlan, as a sensitivity analysis, the primary and secondary goals will be re-analyzed including time of registration as a moderator of the treatment effect.

Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning vs Standard Radiation Treatment Planning

A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning

Compare quality of life as measured by the 6 remaining subscales and 11 single item scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck module (EORTC QLQ-H\&N35). EORTC scores will be recorded at baseline (up to 30 days prior to treatment planning), at the end of Radiation Treatment (+14 days), and 3 months post Radiation Treatment (+/-30 days from 3 months post-radiotherapy). Comparisons between treatment arms will be made using an ANCOVA model with the baseline Patient Reported Outcome (PRO) score included as a covariate and tested at an alpha level of 5%.

DVH statistics will be compared between treatment arms within cohorts of planned radiation dose (30-54 Gy vs. 54-66 Gy vs. 66-76 Gy) and laterality (bilateral vs. unilateral). Comparisons between treatment arms will be made using a two-sided Student's t-test (or Wilcoxon Rank-Sum test for non-normal data) with an alpha level of 5%. All eligible patients who went through treatment planning should be evaluable for this endpoint.

Swallowing score will be measured at baseline (up to 30 days prior to treatment planning), at the end of Radiation Treatment (+ 14 days), and 3 months post Radiation Treatment (+/-30 days from 3 months post-radiotherapy). An ANCOVA model with the baseline Swallowing score as a covariate will be used to test for a significant difference between the two treatment arms at the 5% alpha level. The analysis will be modified intent-to-treat. Specifically, all patients meeting eligibility criteria who have signed a consent form, were randomized, started radiation treatment, and have a scale score within the time window of +/-30 days from 3 months post-radiotherapy will be considered evaluable for this endpoint.

CTCAES will be recorded at baseline (up to 30 days prior to treatment planning), at the end of Radiation Treatment (+14 days), and 3 months post Radiation Treatment (+/-30 days from 3 months post-radiotherapy). Physician-reported toxicities is defined as the dysphasia, dry mouth, and oral pain items from the CTCAE v5.0. The items will be analyzed individually and as a composite. Further, there will be two sets of comparisons: Grade 3+ versus not and Grade 2+ versus not. Comparisons between treatment arms will be made using a Chi-square test with an alpha level of 5%. The analyses will be modified intent-to-treat. Specifically, all patients meeting eligibility criteria who have signed a consent form, were randomized, started radiation treatment, and have toxicity scores within the time window of +/-30 days from 3 months post-radiotherapy will be considered evaluable for this endpoint.

Treatment PQM is a continuous-valued function depending on selected dose-volume histogram statistics for 5 organs-at-risk. Comparisons between treatment arms will be made using a two-sided Student's t-test (or Wilcoxon Rank-Sum test for non-normal data) with an alpha level of 5%. All eligible patients who went through treatment planning should be evaluable for this endpoint. Sensitivity analyses will be conducted for all secondary endpoints where the analyses will be repeated including the interaction of time of registration and treatment group and subgroup analyses for the 3 different allocation ratios will be conducted.

Treatment planning time is defined as the time in minutes from the end of physician contouring to the end of physician plan approval. Comparisons between treatment arms will be made using a two-sided Student's t-test (or Wilcoxon Rank-Sum test for non-normal data) with an alpha level of 5%. All eligible patients who went through treatment planning should be evaluable for this endpoint. Sensitivity analyses will be conducted for all secondary endpoints where the analyses will be repeated including the interaction of time of registration and treatment group and subgroup analyses for the 3 different allocation ratios will be conducted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genomic Testing and Resulting Medical Decisions	NCT03301493	Cancer of Unkno... Cancer Refracto... Cancer of Stoma... Cancer Head Nec... Cancer of Skin Cancer, Lung Cancer Colorect... Cancer of Esoph... Cancer, Bladder Cancer, Uterus Cancer Cervix Cancer Liver Cancer, Kidney Cancer, Breast Hematologic Neo...	Genomic testing	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases	NCT05408871	Cancer Head Nec... Metastatic Canc... Metastatic Lung...	adnectin 18F-BM... adnectin 18F-BM...	18 Years -	Yale University
Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds	NCT05800834	Wounds and Inju... Cancer Pain Cancer, Breast Cancer Head Nec...	Morphine Sulfat... Lidocaine Hcl 2...	18 Years -	Instituto Nacional de Cancer, Brazil
PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)	NCT05745558	Cancer Liver Cancer Head Nec...	Prehabilitation	18 Years -	Erasmus Medical Center
Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp	NCT05987579	Squamous Cell C... Surgery Cancer Head Nec...		18 Years -	Maastricht University Medical Center
PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)	NCT05745558	Cancer Liver Cancer Head Nec...	Prehabilitation	18 Years -	Erasmus Medical Center
Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning vs Standard Radiation Treatment Planning	NCT05979883	Cancer Head Nec... Cancer, Head Cancer Neck	Machine Learnin... Radiation Thera...	18 Years -	Mayo Clinic
Effect of the Use of Symbiotics in Patients With Colon Cancer	NCT04874883	Symbiotic Cancer Colorect... Cancer Head Nec... Intestinal Dysb... Diarrhea Intestinal Micr... Nutritional Sta...	Simbyotic Control Group	18 Years -	Federal University of Minas Gerais
Surgical Treatment of Stage T3 Squamous Cell Carcinomas of the Scalp	NCT05987579	Squamous Cell C... Surgery Cancer Head Nec...		18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for cancer head neck