Sein

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 CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Valérie Théberge
COORDONATEUR(RICE) Josée Allard
josee.allard@chuq.qc.ca
418-525-4444 poste 16730
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  1. Newly diagnosed invasive carcinoma of the breast.

  2. 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.

  3. Breast cancer stage after definitive surgery.

    • 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†

    Note: †Patients who are histologically node positive prior to chemotherapy and who have complete response in the lymph nodes are eligible.

  4. No evidence of metastatic disease.
  5. Candidate for locoregional radiotherapy.
CRITÈRES D'EXCLUSION (EN)
  1. Age < 18 years.
  2. Clinical stages T4 and/or N3.
  3. Clinical lymphedema in the ipsilateral arm or breast/chest wall.
  4. Synchronous or previous contralateral breast cancer.
  5. Breast reconstruction.
  6. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.
  7. 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.
  8. Known pregnancy or currently lactating.
  9. Geographic inaccessibility for follow-up.
  10. Inability to provide informed consent.