Whole Breast Irradiation With Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients

Study Overview
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Brief Summary
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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

Official Title
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Phase 2 Study of Whole Breast Irradiation With Inversely Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: IMRT with an simultaneous integrated boost


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT-SIB<br> | Radiation: IMRT with an simultaneous integrated boost<br>* IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ipsilateral breast recurrence |  | first analysis will occur 5 year after accrual of all patients | 
| Local recurrence rate |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor bed, breast cancer, radiotherapy, simultaneous integrated boost, IMRT