Condition category
Cancer
Date applied
04/03/2014
Date assigned
19/03/2014
Last edited
24/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof Catharine West

ORCID ID

Contact details

Radiotherapy Related Research
University of Manchester
Christie Hospital
Wilmslow Road
Manchester
M20 4BX
United Kingdom
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 measures

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

31/03/2018

Reason abandoned

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

5,300

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, Spain, United Kingdom, United States of America

Trial participating centre

Radiotherapy Related Research
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Prof Nalin Thakker
Christie Building
Oxford Road
Manchester
M13 9PL
United Kingdom
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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes