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

NCT ID: NCT01394575

Last Updated: 2013-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-07-31

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMRT-SIB

Group Type: EXPERIMENTAL

IMRT with an simultaneous integrated boost

Intervention Type: RADIATION

IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed

Interventions

IMRT with an simultaneous integrated boost

IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed

Intervention Type: RADIATION

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.
• Synchronous chemotherapy or target therapy is not permitted.
• Refusal of the patients to be included in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Fudan University Cancer Hospital

Principal Investigators

Jiayi Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The Department of Radiation Oncology, Fudan University Cancer Hospital

Locations

The Department of Radiation Oncology,Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaozhi Yang, MD

Role: CONTACT

yzzhi2006@yahoo.com.cn

862164175590 ext. 6601

Facility Contacts

Zhaozhi Yang, MD

Role: primary

yzzhi2006@yahoo.com.cn

862164175590 ext. 6601

Other Identifiers

BR-RT-001

Identifier Type: -

Identifier Source: org_study_id