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

Not Applicable

Completed

• Conditions: Breast cancer, prostate cancer, lung cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN98496463
• Lead Sponsor: niversity of Manchester (UK)

Brief Summary

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31146072 (added 05/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-19
• Study Completion: 2019-03-31
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4439

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 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)<br> 2. Quality of life<br> 3. Maximum grade of toxicity during follow-up period<br><br> 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.<br> 1. Baseline assessed prior to radiotherapy (all)<br> 2. End of radiotherapy (breast and prostate); or first follow-up visit following implantation for prostate brachytherapy patients<br> 3. 3 months from start of radiotherapy (lung)<br> 4. 6 months from start of radiotherapy (lung)<br> 5. 12 months from start of radiotherapy (all)<br> 6. 24 months from start of radiotherapy (all)<br>