Whole Breast Irradiation With Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients
Phase 2
- Conditions
- Breast Cancer
- Interventions
- Radiation: IMRT with an simultaneous integrated boost
- Registration Number
- NCT01394575
- Lead Sponsor
- Fudan University
- Brief Summary
This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma in situ treated by breast conserving surgery, postoperative whole breast irradiation with inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and local control rate in a single center
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 190
Inclusion Criteria
- Eastern Cooperative Oncology Group performance score﹤2
- All patients aged >18 years and < 70 years after breast conserving surgery.
- On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- Negative nodal status determined by sentinel node biopsy, or axillary dissection. Axillary staging is not required for patients with DCIS
- No evidence of distant metastasis
- Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins（>2mm）
- Surgical treatment of the breast must have been lumpectomy. Re-excision of surgical margins is permitted.
- The patient must consent to be in the study and must have signed an approved consent form.
Exclusion Criteria
- Eastern Cooperative Oncology Group performance score≧2
- Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant of separated.
- Metastatic disease (M1)
- Pregnancy or lactating
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
- Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Prior breast or thoracic RT for any condition.
- Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
- Synchronous chemotherapy or target therapy is not permitted.
- Refusal of the patients to be included in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IMRT-SIB IMRT with an simultaneous integrated boost -
- Primary Outcome Measures
Name Time Method Radiation toxicity first analysis will occur 2 year after accrual of all patients Cosmetic outcome first analysis will occur 2 year after accrual of all patients
- Secondary Outcome Measures
Name Time Method Local recurrence rate first analysis will occur 5 year after accrual of all patients Time to ipsilateral breast recurrence first analysis will occur 5 year after accrual of all patients Disease free survival first analysis will occur 5 year after accrual of all patients Overall survival first analysis will occur 5 year after accrual of all patients
Trial Locations
- Locations (1)
The Department of Radiation Oncology,Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China