Breast cancer, prostate cancer, lung cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
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 ex
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
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States of America
Outcome results
None listed