| TITRE |
Essai randomisé de radiothérapie locorégionale hypofractionnée dans le cancer du sein et le lymphœdème |
| PROTOCOLE ID |
RHEAL |
| CLINICAL TRIAL.gov ID |
NCT04228991 |
| TYPE(S) DE CANCER |
Sein |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
5415 boul. de l'Assomption
(514) 252-3400
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Michael Yassa
|
| COORDONATEUR(RICE) |
Josée Abi-Saad
josee.abi-saad.cemlt@ssss.gouv.qc.ca
514-252-3400 poste 3227
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
