Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

August 4, 2016 updated by: Shu lian Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radiotherapy
radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region
Radiation: radiation
radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
Active Comparator: no radiotherapy
Radiation: no radiation
no radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
loco-regional recurrence
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Chair: ye-xiong Li, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC2008B06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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