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

Fudan University1 site in 1 country190 target enrollmentJuly 2011

ConditionsBreast Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Fudan University
Enrollment: 190
Locations: 1
Primary Endpoint: Radiation toxicity
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

July 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fudan University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Radiation toxicity

Time Frame: first analysis will occur 2 year after accrual of all patients

Cosmetic outcome

Time Frame: first analysis will occur 2 year after accrual of all patients

Secondary Outcomes

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)