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

Phase 2

• Conditions: Breast Cancer

• 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

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-07
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-27
• Primary Completion: 2013-07
• Study Completion: 2013-07

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

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
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

Trial Locations

Locations (1)

The Department of Radiation Oncology,Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China