Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Acute Graft Versus Host Disease

S. Aluwini, MD PhD

P. Veldhuijzen van Zanten

A.C.M Van Den Bergh, MD PhD

The goal is to gain insight in the development and course of the toxicity after a curative treatment of prostate cancer

All with curative intent treated prostate cancer patients will be enrolled in the SFP (Standard Follow-up Programme). It also includes the post -operative adjuvant treatments and the patients with positive lymph nodes.

Patients will complete weekly questionnaires to score the patient -rated toxicity. Biweekly patients are seen by the treating radiation oncologist and / or AIOS in which the physician -rated toxicity is scored. In the follow-up will always patient -rated toxicity and physician -rated toxicity can be determined.

Use of an SFP should yield a profit for the practitioner , such as the automatic generation of letters. This should apply to all SFPs .

Quality of life and toxicity in patients will be completed on the touch-screen computers at FU visits.

Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate

Radiation Induced Toxicity in Prostate Cancer

Sharing data between physicians at the Department of Radiotherapy

Common Terminology Criteria for Adverse Events, version 4.0

* CTCAE 4.0 Constipation
* CTCAE 4.0 Diarrhea
* CTCAE 4.0 Fecal Incontinence
* CTCAE 4.0 Flatulance
* CTCAE 4.0 Proctitis
* CTCAE 4.0 Rectal Hemorrhage
* CTCAE 4.0 Rectal Mucositis
* CTCAE 4.0 Rectal Ulcer
* CTCAE 4.0 Bladder spasm
* CTCAE 4.0 Cystitis Noninfective
* CTCAE 4.0 Hematuria
* CTCAE 4.0 Urinary Frequency
* CTCAE 4.0 Urinary Incontinence
* CTCAE 4.0 Urinary retention
* CTCAE 4.0 Urinary tract Obstruction
* CTCAE 4.0 Urinary tract pain
* CTCAE 4.0 Urinary Urgency
* CTCAE 4.0 Erectile dysfunction

Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function

University Medical Center Groningen

Head and Neck Neoplasms

Radiotherapy (primary or postoperative)

J.A. Langendijk, Prof. Dr.

The primary and general objective of the clinical introduction of the SFP as the current standard of care is to improve the quality of radiotherapy for head and neck cancer patients by reducing radiation-induced side effects without hampering treatment efficacy in terms of locoregional tumour control and overall survival and to systematically evaluate the beneficial effect of newly introduced radiation technology for this particular group of patients. The clinical introduction of the SFP will allow for a systematic and broad scale quality improvement cycle for head and neck cancer patients treated with radiotherapy. In fact, this methodology can be considered a kind of quality circle for the clinical introduction of new radiation techniques, aiming at continuous efforts for further improvement.

Specific objectives

* To develop, validate, and improve normal tissue complication probability (NTCP) models for a wide variety of acute and late radiation-induced side effects relevant for head and neck cancer patients (step 1);
* To use the outcome of the NTCP models to better inform patients on the risks on acute and late toxicity;
* To use the outcome of the NTCP models for the definition of dose constraints for radiotherapy treatment planning in current practice;
* To use the outcome of the NTCP models for the development and investigation of the potential benefit of new and emerging radiation delivery technique, such as swallowing sparing intensity modulation radiation therapy (IMRT) and proton radiotherapy.
* To compare the outcome of new radiation delivery techniques that are clinically introduced with the current standard in terms of radiation-induced toxicity, patient-rated symptoms and quality of life and in terms of locoregional tumour control and overall survival

Standard Follow-up Program (SFP) for Head and Neck Cancer Patients

Standard Follow-up Program (SFP) for Head and Neck Cancer Patients Treated With Curative Primary or Postoperative Radiotherapy or Chemoradiation (SFP Head & Neck)

Laryngo-oesophageal dysfunction-free survival

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Cancer Pain

Pain

Neoplastic Processes

Neurologic Manifestations

Volumetric Intensity-Modulated Arc Therapy

Conventional Radiotherapy

Philip Wong

This study compares the use of conventional radiotherapy technique with volumetric intensity-modulated radiotherapy (VMAT) in the treatment of painful cancer metastases. Half of the patients will receive radiotherapy using a conventional technique, while the other half will receive their treatment using a the VMAT technique.

Radiotherapy to painful sites of metastasis can provide pain relief.

Side-effects from radiotherapy is dependent on the volume and dose received by normal tissues. Conventional radiotherapy techniques delivers similar doses of radiation to the targeted cancer lesion and the normal tissues along the entrance and exit paths of the radiation.

Volumetric intensity-modulated arc therapy (VMAT) is an advanced technique of radiotherapy that spares normal tissues from receiving high-dose irradiation. However, VMAT increases the volume of normal tissues receiving low-dose irradiation.

This study aims at comparing the quality of life and side-effect profiles of patients treated by palliative radiotherapy using the conventional technique vs. VMAT.

Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

A Phase II Randomized Controlled Trial of Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

Time spent in planning and delivering radiotherapy

Change in the daily number of steps taken by patients before and after radiotherapy as measured using an activity tracker

Change in cytokine levels in blood following radiotherapy as a biomarker of response to radiotherapy

Change in circulating microRNA levels in blood following radiotherapy as a biomarker of response to radiotherapy

The global QOL subscale will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. The global QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). Higher scores represent better global QOL.

Quality of life function subscales (physical, role, cognitive, emotional, social and financial functions) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). For function subscales, higher scores represent better function.

Quality of life symptom subscales (dyspnea, pain, fatigue, appetite loss, nausea, constipation, and diarrhea symptoms) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaire and compared to baseline. QOL subscales will be scored according to the EORTC scoring manual (min: 0, max: 100). For symptom subscales, higher scores represent worse symptoms.

Pain response to radiotherapy as defined by the International Bone Metastases Consensus Endpoint Definitions

Descriptive tabulation of toxicities related to radiotherapy as defined by CTCAE v4

Centre hospitalier de l'Université de Montréal (CHUM)

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Budhi S Yadav, MD

In a general radiation oncology practice, breast cancer typically comprises approximately 25% of the total patient caseload.1 Surgery is the primary modality of treatment. Radical mastectomy remained the mainstay of surgical therapy into the 1970s. Breast-conserving surgery followed by radiation therapy to the intact breast is an established standard of care for the majority of women with early stage invasive breast cancer. Recommended techniques for breast-conservation treatment are local excision of the primary tumor, preferably with clear margins, axillary lymph node dissection, and breast irradiation (45 to 50 Gy), usually with a boost (10 to 20 Gy, depending on tumor size and status of the surgical margins).

The aim of this study is to compare the two boost regimen 10Gy/5#/1 week with 16Gy/8#/1.5 weeks in post lumpectomy patients of early stage breast cancer, following whole breast irradiation (WBI).

The study will include 50 patients, (25 in each arm) of early stage post lumpectomy breast cancer patients. Each patient will be treated by WBI followed by tumor bed boost with either electron beam therapy or 3D CRT. The primary end point of the study will be assessment of acute and late radiation toxicities, cosmetic score analysis and local control between two schedules. Secondary end points will be recurrence-free survival.

Patients to be included in this study will be pre-operatively staged according to American Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses TNM staging ) as stage I , stage II of breast carcinoma. Fifty patients of histologically proven post lumpectomy cases of carcinoma breast suitable for whole breast radiotherapy will be enrolled in this study. Patients would be evaluated at the Department of Radiotherapy PGIMER, Chandigarh by doing a thorough clinical examination followed by routine investigations which will include hemogram, liver function tests, kidney function tests, chest X-ray. Patients will be treated by standard rectangular tangential field radiotherapy to whole breast. CT based planning will be done for photons boost and electron beam therapy.

Inclusion criteria

1. Unicentric primary breast cancer with invasive ductal histology. 2. Stage T1, T2, N0, N1, M0 Exclusion criteria

1. Tumor histology with invasive or in situ lobular carcinoma or pure ductal carcinoma in situ.
2. Skin involvement.
3. History of prior primary malignancy.
4. History of prior irradiation to chest
5. Patients who received neoadjuvant chemotherapy. Procedure Fifty patients (25 in each arm) scheduled for whole breast radiotherapy after lumpectomy will be included in this study. An informed written consent in prescribed proforma for all patients will be taken for performing planning CT scan.

Prior to radiotherapy planning, breast conserving surgery in the form of lumpectomy will be carried out in the department of surgery under general anaesthesia. Patients will be recruited 2-3 weeks after lumpectomy. A planning CT scan will be made for each patient. The patients will be positioned on a breast board with sternum parallel to the table, and the ipsilateral arm abducted above the head. Before the CT scan skin marks would be placed to enable the patient repositioning during treatment. Radioopaque markers will be placed to locate the whole breast and lumpectomy cavity on CT images.

Patients will be scanned from level of larynx to the level of upper abdomen, including both lungs with a scan thickness and index of 5mm. The CT scan will include the complete left and right lung, both breasts and the heart. Then CT images will be transferred to the treatment planning system.

The gross tumor volume (GTV) will be defined by lumpectomy cavity contoured on each CT slice. The clinical target volume (CTV) will consist of GTV uniformly expanded in three dimensions by 1cm; however the volume will be constrained to lie 5mm within external contour and up against the pectoralis major muscles. The planning target volume (PTV) will be calculated from the CTV using uniform three dimensional expansion of 0.5 cm. The ipsilateral whole breast will be defined to lie within the radioopaque markers and as deep as the anterior chest wall muscles. The cranial extent of heart will include the infundibulum of right ventricle, the right atrium and right auricle but exclude the pulmonary trunk, ascending aorta and superior vena cava. The lowest external contour of heart will be the caudal border of mediastinum. The pericardium should be excluded from the heart volume. Both lungs will be contoured. The contralateral breast will be contoured as the breast parenchyma is visible on CT images.

After contouring the target volumes and organs at risk (OAR), standard whole breast rectangular field plans, 3D-CRT boost and electron boost plans will be generated. Dose prescribed would be 40 Gy/16#/3 weeks for whole breast rectangular plans and a boost of 10 Gy/5#/1week in arm A and 16Gy/8#/1.5weeks in Arm B. Plans will be evaluated both quantitatively (analyzing dose volume histograms) and qualitatively (by visually inspecting isodose curves). Plans will be inspected for conformity and doses delivered to target and organs at risk.

First follow up will be after 1 month of treatment, subsequently every 2 months till 6 months, 3 monthly till 1 year and 4 monthly till 3 years. Patient will be examined clinically for acute effects, cosmetic outcome and LRR. Required investigation will be done if indicated.

Assessment of toxicity will be done as per RTOG scores AND LENT SOMA scale SKIN Grade0 Grade1 Grade2 Grade3 Grade4 Toxicity No change over baseline Follicular, faint or dull erythema/ epilation/dry desquamation/ decreased sweating Tender or bright erythema, patchy moist desquamation/ moderate edema Confluent, moist desquamation other than skin folds, pitting edema Ulceration, hemorrhage, necrosis Subcutaneous \& cutaneous tissue Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 Toxicity None Slight induration (fibrosis) and loss of subcutaneous fat Moderate fibrosis but asymptomatic Slight field contracture \<10% linear reduction Severe induration and loss of subcutaneous tissue Field contracture \>10% linear measurement Necrosis

Pigmentary change :

0 = None

1. = Transitory , slight
2. = Permanent , marked

Breast edema :

0 = None 1 = Asymptomatic 2 = Symptomatic 3 = Secondary dysfunction

Cosmetic assessment will be done using Harvard/NSABP/RTOG Breast Cosmesis Grading Scale

Statistical analysis The principle end point of the study will be an analysis of acute and late radiation toxicities,cosmetic score analysis and local control between two boost arms. Skin, subcutaneous toxicity and cosmetic assessment will be done before treatment and then in regular follow up of the study. Chi-square test will be used to compare radiation toxicity parameters. Descriptive statistics including mean and standard deviation will be obtained for all variables. A student t-test will be used to compare the dosimetric parameters. p values of \<0.05 will be taken as significant. All tests would be performed using SPSS (Statistical Package for the Social Sciences) v.12.0.

Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast

Acute toxicity will be assessed at at 1 month. Assessment of toxicity will be done as per RTOG scores AND LENT SOMA scale

Pigmentary change scale:

0 = None

1. = Transitory , slight
2. = Permanent , marked

Breast edema:

0 = None 1 = Asymptomatic 2 = Symptomatic 3 = Secondary dysfunction

Cosmetic assessment will be done using Harvard/NSABP/RTOG breast cosmesis grading scale.

Post Graduate Institute of Medical Education and Research, Chandigarh

Assistant Professor

Prostate cancer patients treated with online MR-guided radiotherapy in the Unity MR-linac.

Prostate cancer patients treated with CT-guided radiotherapy (VMAT) in linear accerelators.

Online adaptive MR-guided radiotherapy in the Unity MR-linac for localized intermediate risk prostate cancer (60 Gy/20 fx) or low-volume metastatic prostate cancer (36 Gy/6 fx).

Online MR-guided radiotherapy

CT-guided radiotherapy in linear accelerators for patients with high-risk prostate cancer (78 Gy/39 fx), intermediate risk prostata cancer (60 Gy/20 Fx) or having salvage radiotherapy (70 Gy/35 fx)

CT-guided radiotherapy

Pia KK Møller, MPH

In 2018 the Unity MR-linac was approved for treating patients with online magnetic resonance (MR)-guided radiotherapy. With the MR-linac it is possible to get real-time MR images with high soft tissue contrast, adapt the radiotherapy plan and subsequently irradiate at each treatment fraction. Patients with prostate cancer is one of the patient groups referred for this new treatment and potentially they will benefit with decreased margins around the tumour and increased local tumor control rates.

The acute toxicity is important when evaluating treatment tolerability. A prospective longitudinal observation of the acute treatment toxicity to online MR-guided radiotherapy is therefore essential in the evaluation of this new technology.

Patient-reported outcomes (PRO) are disease symptoms and treatment toxicity reported directly by patients themselves without clinician interpretation. Several studies have indicated that clinicians tend to underreport the incidence and severity of patient symptoms, thus a systematic use of PROs in clinical trials can provide valuable evidence to the clinicians. As online MR-guided radiotherapy (MRgRT) is a new technology there is limited research worldwide on patient-reported symptoms and quality of life.

The objective of this study is therefore to prospectively investigate the patient-reported acute toxicity and changes in quality of life during and after online MR-guided radiotherapy.

Background:

In 2018 the first patients worldwide were treated with the first 1.5 T MR-linac. The MR-linac is innovative technology in cancer treatment making precision radiotherapy possible, as it is a linear accelerator mounted on a ring around a 1.5-Tesla MRI Scanner combined with an online adaptive radiotherapy planning system. When the patient is positioned in the MR-linac it is possible to get real-time MR images with high soft tissue contrast, adapt the radiotherapy plan and subsequently irradiate at each treatment fraction. The improved visualization on the MR images makes it possible to see how the tumour and the organs around it changes and adapt the treatment plan every day. This opens up for a reduction of safety margins needed to insure target coverage and increased use of hypo- fractionation. Cancer patients will hopefully benefit from this with decreased treatment toxicity and increased local tumor control rates.

Today, computed tomography (CT)-guided intensity-modulated radiotherapy is standard treatment for patients with pelvic or abdominal tumors. However, the visualization of the tumor and surrounding tissue is poor due to low soft-tissue contrast in the cone-beam scans. When using MRI for online radiotherapy planning in pelvic and abdominal sites, the soft-tissue contrast will be high making it possible to improve contouring accuracy and reduce margins. The potential of the MR-linac lowering treatment toxicity can greatly impact survivorship and quality of life. This would particularly be beneficial for patients diagnosed with cancer in the pelvic region, like prostate cancer, having considerably high chances of survival.

The standard for toxicity monitoring in cancer clinical trials is the prospective clinician reporting of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grading, as well as patient-reported outcomes (PRO), is also part of the proposed standard assessment methodology for clinical evaluation of radiotherapy innovations like online MRgRT. Several studies have identified discrepancies between clinician and patient reporting within systemic treatment where clinicians appear to underreport the severity of treatment toxicity, compared to patient-reported severity. Therefore, patient self-reports are an important supplement to the evaluation of online MRgRT as in other oncological settings where they have been used as direct indicators of worsening, persistence or improvement of symptoms and general well-being. Furthermore, patient self-reports reduces the risk of unanticipated treatment toxicities being undetected.

Methods:

Study Design:

The study is a prospective single-arm longitudinal observational study including all prostate cancer patients treated with online MR-guided radiotherapy or CT-guided radiotherapy in the study period.

Participants:

Patients with prostate cancer referred for radiotherapy at Odense University Hospital in the time period 15.11.2020 - 01.07.2022 will be eligible for inclusion.

Data collection:

A patient pathway app, My Hospital, will be used for data collection. A PRO item set for patients with prostate cancer has been developed and tested in a pilot study (PRO-CTCAE and EORTC items). The item set will be used weekly during treatment and 4 weeks following to capture expected and unanticipated symptoms of acute treatment toxicity. During follow-up patients wll be asked to report 8, 12 and 24 weeks after radiotherapy completion. Other questionnaires will be used to measure quality of life (EORTC QLQ-C30+EORTC PR25), health-related quality of life (EQ-5D-5L), patient experience with ePRO (Patient Feedback Form) and patient experience with treatment on a 1.5 T Unity MR-linac (Patient Experience Questionnaire).

Data on clinician management of PROs will be drafted from the patient app My Hospital.

Only patients with prostate cancer and therefore only male participants.

PRO-MR-RT Systematic Patient-reported Outcomes to Pelvic Online MRgRT

PRO-MR-RT Systematic Web-based Patient-reported Outcomes for a Personalized, Patient-centered Symptom Management and Clinical Assessment of Pelvic Toxicity to Magnetic Resonance Radiation Therapy

A two-level increase from baseline in the PRO-CTACE item urinary frequency scored on a 5-point likert scale (0 being abscence of symptom, 4 being highest frequency) for minimum two consecutive symptom-reports.

Mean change in QoL from baseline to follow-up week 12. Measured with the questionnaires EORTC QLQ-C30 and Euroqol EQ-5D-5L.

The patients are to report how weekly ePROs with real-time feedback in their course of radiotherapy impact their involvement, the quality of care and communication with clinicians. Patient satisfaction is measured with questions from the validated Patient Feedback Form on a 4-point likert scale (strongly agree, agree, disagree, strongly disagree).

A pelvic item set developed and tested in a pilot study is used to capture symptomatic adverse events (AEs). This item set includes PRO-CTCAE items (5-point likert scale, 0 being absence of symptoms) and EORTC items (4-point likert scale, 1 being absence of symptoms). Median number of weeks to first maximum worsening of the adverse events are measured. Persistence of symptoms is measured as being \> baseline score until 12 weeks following radiotherapy.

Patient experience with online MR-guided radiotherapy will be measured with a questionnaire specifically developed and validated to capture patient experience in a MR-linac (4-point likert scale).The questionnaire will also be tested on patients undergoing CT-guided radiotherapy to descriptively look at the differences in the two cohorts.

Novo Nordisk A/S

AgeCare Academy of Geriatric Cancer Research

Odense University Hospital

BN, MPH, Phd Student

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Radiotherapy

CT Muijs, MD PhD

Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.

Goal:

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate	NCT03034187	Prostate Cancer		18 Years -	University Medical Center Groningen
Standard Follow-up Program (SFP) for Head and Neck Cancer Patients	NCT02435576	Head and Neck C...	Radiotherapy (p...	18 Years -	University Medical Center Groningen
Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain	NCT03374592	Neoplasm Metast... Pain Radiotherapy Si... Quality of Life	Volumetric Inte... Conventional Ra...	-	Centre hospitalier de l'Université de Montréal (CHUM)
Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain	NCT03374592	Neoplasm Metast... Pain Radiotherapy Si... Quality of Life	Volumetric Inte... Conventional Ra...	-	Centre hospitalier de l'Université de Montréal (CHUM)
Evaluation of Two Boost Radiation Schedules in Post Lumpectomy Early Stage Carcinoma Breast	NCT02142907	Breast Cancer Adverse Effect ...		20 Years - 75 Years	PGIMER
PRO-MR-RT Systematic Patient-reported Outcomes to Pelvic Online MRgRT	NCT05615909	Prostate Cancer	Online MR-guide... CT-guided radio...	18 Years -	Odense University Hospital
Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer	NCT02454790	Esophageal Canc...	Radiotherapy	18 Years -	University Medical Center Groningen
Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer	NCT02454790	Esophageal Canc...	Radiotherapy	18 Years -	University Medical Center Groningen

Spots Global Cancer Trial Database for acute toxicity