Condition category
Cancer
Date applied
04/03/2014
Date assigned
19/03/2014
Last edited
29/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Catharine West

ORCID ID

http://orcid.org/0000-0002-0839-3449

Contact details

Radiotherapy Related Research
University of Manchester
Christie Hospital
Wilmslow Road
Manchester
M20 4BX
United Kingdom
0161 446 8275
catharine.west@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

601826

Study information

Scientific title

Validating predictive models and biomarkers of radiotherapy toxicity to reduce side effects and improve quality of life in cancer survivors: a prospective observational cohort study

Acronym

REQUITE

Study hypothesis

Primary objective: To establish a prospective cohort of patients undergoing radiotherapy for breast, prostate or lung cancer following local regimens and collecting standardised radiotherapy toxicity data, non-genetic risk factor data and samples for biomarker assays for the study of determinants of radiotherapy side-effects.

Secondary objective: To establish a comprehensive centralised database and sample collection as a resource for the prospective evaluation and validation of clinical models incorporating biomarker data to identify before treatment those cancer patients who are at risk of developing long-term side effects from radiotherapy.

Ethics approval

UK ethics approval obtained from North West - GM East REC, ref: 14 NW 0035

Study design

Prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer, prostate cancer, lung cancer

Intervention

A pre-treatment blood sample will be collected from every patient at a single time point for downstream analyses. This sample comprises:
Sample A: a whole blood EDTA sample for DNA extraction
and either
Sample B: a whole blood PAXgene sample for RNA extraction
or
Sample C: a whole blood Lithium Heparin sample for the apoptosis assay.

Toxicity will be assessed and documented using REQUITE toxicity questionnaires based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 and EORTC Quality of Life. At some sites additional questionnaires will also be used: Multiple Fatigue Inventory (MFI) and the General Practice Assessment
Questionnaire (GPAQ). Questionnaires will be completed at the following time points:
1. Baseline assessed prior to radiotherapy (all)
2. End of radiotherapy (breast and prostate); or first follow-up visit following implantation for prostate brachytherapy patients
3. 3 months from start of radiotherapy (lung)
4. 6 months from start of radiotherapy (lung)
5. 12 months from start of radiotherapy (all)
6. 24 months from start of radiotherapy (all)

The follow-up period can be extended beyond 24 months. Further follow-up will be permissible and encouraged where possible as part of routine clinical care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

1. Change in breast appearance at 24 months following start of radiotherapy (breast) measured by digital photograph
2. Rectal bleeding at 24 months following start of radiotherapy (prostate) measured by patient-reported outcome toxicity questionnaires
3. Dyspnea/breathlessness at 12 months following start of radiotherapy (lung) measured by patient-reported outcome toxicity questionnaires

Secondary outcome measures

1. Other toxicity endpoints including but not limited to: fibrosis, induration and vascular changes (breast); rectal incontinence, urinary toxicity and erectile dysfunction (prostate); dysphagia and oesophagitis (lung)
2. Quality of life
3. Maximum grade of toxicity during follow-up period

Toxicity will be assessed and documented using REQUITE toxicity questionnaires based on the CTCAE v4.0 and EORTC Quality of Life at the following time points.
1. Baseline assessed prior to radiotherapy (all)
2. End of radiotherapy (breast and prostate); or first follow-up visit following implantation for prostate brachytherapy patients
3. 3 months from start of radiotherapy (lung)
4. 6 months from start of radiotherapy (lung)
5. 12 months from start of radiotherapy (all)
6. 24 months from start of radiotherapy (all)

Overall trial start date

01/04/2014

Overall trial end date

31/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients suitable for adjuvant radiotherapy* for cancer of the breast (invasive or in situ) including breast patients receiving neo-adjuvant chemotherapy
2. Patients suitable for radical radiotherapy or brachytherapy for prostate cancer; including post-prostatectomy patients
3. Patients suitable for radical radiotherapy, sequential or concurrent chemoradiotherapy or stereotactic body radiation therapy for lung cancer
4. No other malignancy prior to treatment for the specified tumour types except basal cell or squamous cell carcinoma of the skin
5. No evidence of distant metastases
6. Patients able to provide a venous blood sample
7. Willingness and ability to comply with scheduled visits, treatment plans and available for follow-up within country of origin
8. Greater than 18 years of age; no upper age limit
9. The capacity to understand the patient information sheet and the ability to provide written informed consent

*Breast patients receiving chemotherapy should have completed their course of chemotherapy (anthracyclines) at least one month prior to radiotherapy commencing.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4439

Participant exclusion criteria

1. Patients with metastatic disease
2. Prior irradiation at the same site
3. Planned use of protons
4. Breast patients receiving concomitant chemo-radiation
5. Male breast cancer patients
6. Mastectomy patients
7. Bilateral breast cancer
8. Small cell lung cancer
9. Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires
10. Limited life expectancy due to co-morbidity
11. Pregnant patients
12. Partial breast irradiation
13. Patients with breast implants if not removed during surgery
14. Patients with known HIV infection/infectious hepatitis

Recruitment start date

01/04/2014

Recruitment end date

31/03/2018

Locations

Countries of recruitment

Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States of America

Trial participating centre

Radiotherapy Related Research
Manchester
M20 4BX
United Kingdom

Trial participating centre

Centre d'imagerie de l'ICM Val d'Aurelle - Groupe CRP
Institut du Cancer 31 rue Croix Verte
Montpellier
34000
France

Trial participating centre

MAASTRO clinic
Doctor Tanslaan 12
Maastricht
6229 ET
Netherlands

Trial participating centre

Icahn School of Medicine at Mount Sinai
1 Gustave L. Levy Place
New York
10029
United States of America

Trial participating centre

The Christie NHS Foundation Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Trial participating centre

Fundación Publica Galega Medicina Xenomica
CHUS Edif Consultas, floor -2 Choupana s/n
Santiago de Compostela
15706
Spain

Trial participating centre

Fondazione IRCCS Istituto Nazionale dei Tumori
Via Giacomo Venezian, 1
Milan
20133
Italy

Trial participating centre

University Hospital Leuven
Herestraat 49
Leuven
3000
Belgium

Trial participating centre

Universitair Ziekenhuis Gent
Corneel Heymanslaan 10
Ghent
9000
Belgium

Trial participating centre

Universitaet Mannheim
Mannheim
68131
Germany

Trial participating centre

Fundació Privada Institut d'Investigació Oncológica Vall d'Hebron
Centro Cellex Calle Natzaret 115-117
Barcelona
08035
Spain

Trial participating centre

University Hospitals of Leicester
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Städtisches Klinikum Karlsruhe
Moltkestraße 90
Karlsruhe
76133
Germany

Trial participating centre

St. Vincentius-Kliniken gAG Karlsruhe
Steinhäuserstraße 18
Karlsruhe
76137
Germany

Trial participating centre

Klinikum der Stadt Ludwigshafen GmbH
Bremserstraße 79
Ludwigshafen am Rhein
67063
Germany

Trial participating centre

Praxis Strahlentherapie
Paul-Egell-Straße 31
Speyer
67346
Germany

Trial participating centre

Zentrum für Strahlentherapie
Wirthstraße 11c
Freiburg im Breisgau
79110
Germany

Trial participating centre

Klinikum Darmstadt
Grafenstraße 9
Darmstadt
64283
Germany

Trial participating centre

Strahlentherapie An der Stadtklinik
Balger Str. 50
Baden-Baden
76532
Germany

Trial participating centre

The Institute for Cancer Research and Treatment
Strada Provinciale
Candiolo
10060
Italy

Trial participating centre

Derby Hospitals NHS Foundation Trust
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Salford Royal Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

Birmingham NHS Foundation Trust
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Centre Hospitalier Régional Universitaire de Nîmes
4 Rue du Professeur Robert Debré
Nîmes
30029
France

Trial participating centre

Memorial Sloan Kettering Cancer Centre
1275 York Ave
New York
10065
United States of America

Trial participating centre

Queens Cancer Centre
82-68 164th Street New-Bldg 5th Floor Jamaica
New York
11432
United States of America

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Lynne MacRae
Faculty of Biology
Medicine and Health
The University of Manchester
Room 1.21a Simon Building
Brunswick Street
Manchester
M13 9PL
United Kingdom
+44 161 275 5436
research-governance@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

European Union - Seventh Framework Programme for Research, Technological Development and Demonstration, Ref. 601826

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

IPD sharing statement:
We have an extensive resource of treatment, toxicity & PRO data as well as DVH & DICOM, genotyping & breast photos. It is accessible to all (following submission and approval of a concept form). Researchers can find out top level data on numbers of patients with particular characteristics using our ‘Data Discovery’ link off the website. Our CRFs are available on the website for use by others to improve standardisation of data collection in the field. A baseline manuscript is in preparation describing the cohort in detail.

Intention to publish date

30/09/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/11/2018: Cancer Research UK lay results summary link added to Results (plain English). 13/08/2018: ICM-Val d'Aurelle, MAASTRO clinic, Icahn School of Medicine at Mount Sinai, The Christie NHS Foundation Trust, Fundación Publica Galega Medicina Xenomica, Fondazione IRCCS Instituto Nazionale dei Tumori, University Hospital Leuven, Universitair Ziekenhuis Gent, Universitaet Mannheim, Fundació Privada Institut d'Investigació Oncológica Vall d'Hebron, University Hospitals of Leicester NHS Foundation Trust, Städtisches Klinikum Karlsruhe, St. Vincentius-Kliniken gAG, Klinkikum der Stadt Ludwigshafen GmbH, Praxis Strahlentherapie, Zentrum für Strahlentherapie Freiburg,b Klinikum Darmstadt GmbH, Strahlentherapie An der Stadtklinik, The Institute for Cancer Research and Treatment, Derby Hospitals NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Salford Royal Foundation Trust, Birmingham NHS Foundation Trust, Centre Hospitalier Régional Universitaire de Nîmes, Memorial Sloan Kettering Cancer Centre, and Queens Cancer Centre were added as trial participating centres. 09/08/2018: The following changes were made to the trial record: 1. ORCID ID and telephone number added to contact details 2. Telephone number and address updated for sponsor 3. The overall trial end date was changed from 31/03/2018 to 31/09/2019 4. The target number of participants was changed from 5300 to 4439 5. The total target enrolment was changed from 5300 to 4439 6. The Netherlands was added as a country of recruitment. 7. Participant level data was changed from "not provided at time of registration" to "available on request" 8. The publication and dissemination plan was updated 9. The intention to publish date was added.