Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Rare Diseases

Renal Insufficiency

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Germ Cells Tumors

Testicular Germ Cell Tumor

Danish patients with germ cell cancer diagnosed from 1984 to 2007.

Gedske Daugaard, MD DMSc

The purpose of this study is to identify genetic variations in survivors of testicular cancer and connect these variations to differences in risks of late effects.

Identification of late-effects through questionnaires and linkage to national registries. DNA samples will be gathered through buccal swabs or saliva kits and analysed with whole exome-sequencing.

Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors

Identify genetic variations predicting renal toxicity.

Rigshospitalet, Denmark

Professor M.D. DMSc

Behaviors and Mental Disorders

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

Skin and Connective Tissue Diseases

Wounds and Injuries

Breast Neoplasms

Radiation Injuries

Breast Diseases

Skin Diseases

Hyperbaric oxygen therapy consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions the pressure will be raised to 2.4 atmospheres absolute in a hyperbaric chamber and patients breath in 100% oxygen during 4 times 20 minutes.

Usual care may consist of physiotherapy, analgetics, edema therapy

Hyperbaric oxygen therapy in a multiperson hyperbaric oxygen chamber. Standard hyperbaric oxygen therapy provided as reimbursed by insurers.

Hyperbaric oxygen therapy

Helena M Verkooijen, MD, PhD

The "Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity" (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design.

Objective: The aim of this study is to assess whether HBOT reduces pain, and improves physical functioning and QoL in breast cancer patients with late radiation toxicity.

Study design: Randomized controlled trial, nested within the prospective UMBRELLA breast cancer cohort according to the TWiC's design. UMBRELLA is a prospective cohort study including all breast cancer patients visiting the University Medical Center (UMC) Utrecht department of Radiotherapy. In total 120 patients will be randomized in a ratio of 2:1.

Study population: Breast cancer patients participating in the UMBRELLA cohort who have given informed consent to be invited for future research (e.g. cmRCT's), and who have reported symptoms of late radiation toxicity.

Intervention: Eligible patients will be referred to the HBO center for a standard HBO treatment. HBOT consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions patients breath in 100% oxygen during 4 times 20 minutes in a hyperbaric chamber.

Main study parameters/endpoints: The primary endpoint of this study is patient reported breast/chest wall pain. Secondary endpoints are: physical functioning, QoL cosmetic outcome, physician reported pain and radiation toxicity (according to CTCAE criteria version 4.03, tissue oxygenation previous to HBOT and after HBOT and side-effects of HBOT.

The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial

The Effect of Hyperbaric Oxygen Therapy on Breast Cancer Patients With Late Radiation Toxicity

The primary endpoint of this study is the difference in proportion of patient-reported breast/chest wall pain grade 3-4 between control and intervention group. Pain is assessed by means of the EORTC QLQ-BR23 questionnaire on a 4-point Likert scale. At baseline all patients have a pain score of 3 or 4 (see inclusion criteria). The proportion of patients with 3-4 at 6 months will be compared between intervention and control group. A higher score indicates more pain.

Quality of life (QoL) measured by European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. QoL will be scored on a scale of 0-100. A higher score indicates a better outcome. Change in score between baseline and 6 months will be compared between intervention and control group.

Late radiation toxicity is assessed by means of a late radiation toxicity questionnaire (ability to move the arm, (breast) edema, fibrosis) in both control group and intervention group. Change in patient reported late radiation toxicity will be compared between intervention and control group. Late radiation toxicity will be assessed on a 4-point Likert scale. A higher score indicates worse outcomes.

Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 only in intervention group. CTCAE criteria are assessed on a scale of 0-3.

Assessed by means of the breast cancer questionnaire (BREAST-Q) in both control group and intervention group. BREAST-Q scores will be assessed using the BREAST-Q scoring tables.

Reported by means of medical photograph (cosmetic outcome judged by group of experts and "Breast Cancer Conservative Treatment - cosmetic results" (BCCT.core) program) and with physical examination using the Patient and Observer Scar Assessment Scale (POSAS) score v2.0. Physician reported cosmetic outcome will only be assessed in the intervention group.

Side effects of HBOT will be monitored using the MacFie classification only in the intervention group.

Skin oxygenation will be measured prior to HBOT and after last treatment session using transcutaneous oxygen measurement. The contralateral breast will be used as a reference. Only assessed in the intervention group.

UMC Utrecht

Prof. dr.

Simultaneous Integrated Boost Technique

In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.

Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique

Toxicity score using Common Terminology for Adverse Events (CTCAE)

Questionnaires: European Organization for Research and Treatment of Cancer Quality of Life - Core Questionnaire (EORTC QLQ-C30), Quality of Life Questionnaire - Breast Cancer Module (QLQ-BR23) and Adult Comorbidity Evaluation (ACE-27)

Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound

Carcinoma

All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive, who respond to our invitation letter and are willing to participate to visit the outpatient clinic. These patients will be sent a questionnaire with both basic and more detailed questions on their disease-status and on quality of life related outcome. In addition they will be asked to come to MAASTRO clinic for a more detailed evaluation of late side effects of the treatment. Patients are seen by a physician or a physician assistant at the outpatient clinic.

The participants are seen at the outpatient clinic by a physician or a physician assistant. To analyse fibrosis clinical examination of the breast will be performed. To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured. To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides). Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures. Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank.

Outpatient clinic

Liesbeth J Boersma, M.D., Ph.D.

In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.

There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.

The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.

The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.

As part of the study a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank. The purpose to determine, by means of DNA and protein analysis, the relationship between DNA and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects.

For detailed information: ClinicalTrials.gov Identifier: NCT01084785

Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.

Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.

The following the potential risk factors are recorded:

1. Patient related risk factors:

   * Age at time of diagnosis
   * Genetic and protein profile blood samples (optional with informed consent of participant)
   * Smoking
2. Treatment related factors:

   * Type of surgery
   * Excision volume
   * Post-operative complications
   * Resection margins Free
   * Scar visibility
   * Axillary surgery
   * Radiotherapy
   * Fractionation scheme
   * Target volumes
   * Dose-volume parameters
   * Actually delivered dose
   * Chemotherapy
   * Hormonal treatment
   * Immunotherapy
3. Tumor related factors

   * Localization
   * Stage
   * Differentiation grade
   * Hormonal receptors
   * HER-2
   * Genetic profile

As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain \[Barnett et al, 2012\].

The secondary endpoint is 10 year survival rate, and late toxicity, other than locoregional late toxicity, e.g. fatigue, neuropathy, menopausal symptoms, cardiac and pulmonary symptoms, and secondary tumors. Survival will be divided in overall survival, locoregional recurrence free survival and distant metastases free survival. For each patient other toxicity at 10 year will be scored according to CTC-AE 4.

Maastricht Radiation Oncology

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
Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors	NCT02303015	Germ Cell Cance...		15 Years -	Rigshospitalet, Denmark
Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate	NCT03034187	Prostate Cancer		18 Years -	University Medical Center Groningen
Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors	NCT02303015	Germ Cell Cance...		15 Years -	Rigshospitalet, Denmark
Standard Follow-up Program (SFP) for Head and Neck Cancer Patients	NCT02435576	Head and Neck C...	Radiotherapy (p...	18 Years -	University Medical Center Groningen
The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial	NCT04193722	Breast Cancer Radiation Toxic...	Hyperbaric oxyg...	18 Years -	UMC Utrecht
Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique	NCT02505906	Breast Cancer	Simultaneous In...	18 Years -	University Medical Center Groningen
The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial	NCT04193722	Breast Cancer Radiation Toxic...	Hyperbaric oxyg...	18 Years -	UMC Utrecht
Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.	NCT01978756	Breast Cancer	Outpatient clin...	18 Years -	Maastricht Radiation Oncology
Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique	NCT02505906	Breast Cancer	Simultaneous In...	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
The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial	NCT04193722	Breast Cancer Radiation Toxic...	Hyperbaric oxyg...	18 Years -	UMC Utrecht
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 late toxicity