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
|