NCT00805597

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

3.7 years

First QC Date

December 8, 2008

Last Update Submit

August 4, 2016

Conditions

Breast Cancer

Keywords

breast cancermastectomyone to three positive nodesradiotherapy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    10 years

Secondary Outcomes (1)

  • loco-regional recurrence

    5 years

Study Arms (2)

radiotherapy

EXPERIMENTAL

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

Radiation: radiation

no radiotherapy

ACTIVE COMPARATOR

no radiotherapy

Radiation: no radiation

Interventions

radiationRADIATION

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

radiotherapy
no radiationRADIATION

no radiotherapy

no radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Ye-xiong Li, M.D.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 9, 2008

Study Start

June 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations

CN(1)