Titre Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer
Protocole ID OSU-16106
ClinicalTrials.gov ID NCT02927912
Type(s) de cancer Sein
Phase Phase II
Type étude Clinique
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dr Rami Younan
Coordonnateur(trice) Mom Phat
 514-890-8000 poste 11171
Statut Fermé
Critètes d'éligibilité
  • Pathologically proven diagnosis of breast cancer
  • Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
    • Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
  • Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
  • History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
  • Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
  • Absolute neutrophil count > 1800 cells/cubic mm
  • Platelets >= 75,000 cells/cubic mm
  • Hemoglobin >= 8 g/dL
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
  • Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
  • Patients must provide study specific informed consent prior to study entry
Critètes d'exclusion
  • Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
  • Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
  • Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
  • Two or more cancers not resectable through a single lumpectomy incision
  • Bilateral breast cancer
  • Ductal breast carcinoma in situ (DCIS) only
  • Non-epithelial breast malignancies such as sarcoma/lymphoma
  • Male breast cancer
  • Paget's disease of the nipple
  • Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
  • Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
  • Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent