REQUITE: Validating predictive models and biomarkers of radiotherapy toxicity to reduce side-effects and improve quality-of-life in cancer survivors

With increasing life expectancies and improvements in diagnosis and treatment,
the number of cancer patients and survivors is expected to continue to rise. As
the illness increasingly becomes a chronic disease, cancer patients*
quality-of-life needs to be addressed in a systematic manner in order to
enhance their participation in society, including the workplace. Approximately
half of all cancer patients receive radiotherapy as part of their cancer
treatment. The dose of radiation given is limited because of a risk of damaging
the normal tissues and organs that surround the tumour. Patients vary in how
they react to radiation. About 5% of patients (5 out of every 100) are
sensitive and at risk of having side effects. In recent years predictive models
have been developed that attempt to identify before the start of treatment
patients at risk of long-term side-effects. These emerging models require
systematic validation in a multi-centre collaborative setting. There are an
increasing number of datasets available for validation but they are variable in
terms of the data collected.
This multi-centre observational study will be the largest study of its kind
collecting blood samples and standardised data longitudinally from 5,300 cancer
patients. It will enable validation of models that predict a patient*s risk of
developing long-term side-effects following radiotherapy. It will be a unique
(eventually widely accessible) resource for studying the relationships between
side-effect endpoints and between side-effects and quality-of-life. It is known
that genetics influence a patient*s risk of developing side-effects and a
number of assays/approaches have been explored to assess a patient*s
sensitivity to radiation. This prospective observational study will allow for
the validation of the most promising biomarkers/approaches.

Primary Objective

To establish a prospective cohort of patients undergoing radiotherapy for
breast, prostate or lung cancers 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.

This is an international observational cohort study. Eligible patients will
have cancer of the breast (invasive or in situ), prostate or lung and be due to
receive radical radiotherapy or adjuvant radiotherapy after breast conserving
surgery or prostatectomy. Patients will be recruited from participating
outpatient oncology clinics via cancer centres in multiple countries including
Belgium, France, Germany, Italy, Spain, The Netherlands, UK and USA. Data on
radiotherapy toxicity, non-genetic risk factors (e.g. dosimetry, chemotherapy
use, age, diabetes, smoking history, co-morbidity) and quality of life will be
collected at specified time points prospectively. Pre-treatment blood samples
will be collected from all patients for downstream analyses. Patients will be
required to have understood information about the study and given written
informed consent.

REQUITE is an observational study and the treatment will not change by taking
part in this study. Patients will be asked to complete some questionnaires and
to give a blood sample. Potential harms of taking blood are a large bruise
(haematoma) or extremely rarely impairment of nerves. There will be no direct
benefit for the patient.