Titre Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction
Protocole ID MAC.23
ClinicalTrials.gov ID NCT03414970
Type(s) de cancer Sein
Phase Phase III
Type étude Autre
Institution CISSS DE L'OUTAOUAIS
   HOPITAL DE GATINEAU
      909 Boulevard La Vérendrye, Gatineau, QC, J8P 7H2
Ville Gatineau
Investigateur(trice) principal(e) Dr Robert Archambault
Coordonnateur(trice) Isabelle Laforest
819-966-6100 poste 3669
Statut Actif en recrutement
Date d'activation 15-01-2019
Critètes d'éligibilité
  • Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); in-situ disease alone is not allowed
  • Final American Joint Committee on Cancer (AJCC) stage IIa - IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status); pathological stage for all patients not receiving neoadjuvant chemotherapy; higher of the clinical or pathological T and N stage, if receiving neoadjuvant chemotherapy; patients with pathological N0 at the time of mastectomy are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to induction chemotherapy
  • No prior radiation therapy to the chest, neck or axilla
  • No prior history of ipsilateral breast cancer (invasive disease or ductal breast carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
  • No history of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
  • No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis
  • Negative inked histologic margins from mastectomy pathology (no invasive cells at margin)
  • No significant post mastectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable
  • Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended)
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
  • Radiation oncologist is NOT planning to utilize a chest wall/scar boost
  • Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 8 months after radiation
  • For patients with diabetes, hemoglobin A1C test must have been performed =< 90 days prior to registration
  • No co-existing medical conditions with life expectancy < 5 years
  • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
  • Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =< 7 days prior to registration; a female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
  • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
Critètes d'exclusion