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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
radiation
no radiation
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, mastectomy, one to three positive nodes, radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

radiotherapy

no radiotherapy

Arm Description

radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region

no radiotherapy

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

loco-regional recurrence

Full Information

First Posted
December 8, 2008
Last Updated
August 4, 2016
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00805597
Brief Title
Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
Official Title
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
The recuiting was to slow to complete the study
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, mastectomy, one to three positive nodes, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy
Arm Type
Experimental
Arm Description
radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region
Arm Title
no radiotherapy
Arm Type
Active Comparator
Arm Description
no radiotherapy
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
Intervention Type
Radiation
Intervention Name(s)
no radiation
Intervention Description
no radiotherapy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
10 years
Secondary Outcome Measure Information:
Title
loco-regional recurrence
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye-xiong Li, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

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

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