A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

Chinese Academy of Medical Sciences1 site in 1 country40 target enrollmentJune 2008

ConditionsBreast Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Chinese Academy of Medical Sciences
Enrollment: 40
Locations: 1
Primary Endpoint: overall survival
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.

Detailed Description

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

February 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Chinese Academy of Medical Sciences

Responsible Party

Principal Investigator

Shu lian Wang

M.D.

Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Ipsilateral histologically confirmed invasive breast cancer
•Undergone total mastectomy and axillary dissection
•T1-2 and one to three axillary lymph nodes positive
•A minimum of 10 axillary nodes dissected
•Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
•Written,informed consent

Exclusion Criteria

•Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
•Previous or concurrent malignant other than non-melanomatous skin cancer
•Unable or unwilling to give informed consent