Whole Breast Irradiation With Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients (IMRT-SIB)

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer

Treatments

Radiation: IMRT with an simultaneous integrated boost

Study type

Interventional

Funder types

Other

Identifiers

NCT01394575

BR-RT-001

Details and patient eligibility

About

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

Enrollment

190 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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