| Title |
Randomized Trial of Hypofractionated LocoRegional Radiotherapy in Breast Cancer and Lymphedema |
| Protocole ID |
RHEAL |
| ClinicalTrials.gov ID |
NCT04228991 |
| Cancer Type(s) |
Breast |
| Phase |
Phase III |
| Stage |
|
| Study Type |
Clinical |
| Drug |
|
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Pierre Rousseau
|
| Coordinator |
Mom Phat
514-890-8000 poste 11171
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility Criteria |
- Newly diagnosed invasive carcinoma of the breast.
-
Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.*
Note: *Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible.
-
Breast cancer stage after definitive surgery.
Note: †Patients who are histologically node positive prior to chemotherapy and who have complete response in the lymph nodes are eligible.
- if neoadjuvant chemotherapy was not administered: pathologic stage T1-3, N1-2
- if neoadjuvant chemotherapy was administered: clinical stage T1-3, N1-2 (histologically node positive) and pathologic stage T0-3, N0-2†
- No evidence of metastatic disease.
- Candidate for locoregional radiotherapy.
|
| Exclusion Criteria |
- Age < 18 years.
- Clinical stages T4 and/or N3.
- Clinical lymphedema in the ipsilateral arm or breast/chest wall.
- Synchronous or previous contralateral breast cancer.
- Breast reconstruction.
- History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.
- Previous radiotherapy to the ipsilateral breast or chest wall or serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy.
- Known pregnancy or currently lactating.
- Geographic inaccessibility for follow-up.
- Inability to provide informed consent.
|
| |
|
Groupe d'étude en oncologie du Québec