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History of Changes for Study: NCT00793962
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-Risk Breast Cancer
Latest version (submitted October 9, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 17, 2008 None (earliest Version on record)
2 February 13, 2012 Sponsor/Collaborators, Arms and Interventions, Study Status and Study Identification
3 January 28, 2014 Study Status, Contacts/Locations and Eligibility
4 February 3, 2015 Study Status
5 January 29, 2016 Study Status and Study Design
6 August 4, 2016 Recruitment Status, Study Status and Contacts/Locations
7 July 20, 2017 Study Status, Outcome Measures and Study Design
8 October 9, 2018 Recruitment Status and Study Status
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Study NCT00793962
Submitted Date:  November 17, 2008 (v1)
Open or close this module Study Identification
Unique Protocol ID: LC2008A06
Brief Title: A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-Risk Breast Cancer
Official Title: A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-Risk Breast Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2008
Overall Status: Recruiting
Study Start: June 2008
Primary Completion: October 2010 [Anticipated]
Study Completion: October 2015 [Anticipated]
First Submitted: November 17, 2008
First Submitted that
Met QC Criteria:		 November 17, 2008
First Posted: November 19, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:		 November 17, 2008
Last Update Posted: November 19, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Chinese Academy of Medical Sciences
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.
Detailed Description:

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
Open or close this module Conditions
Conditions: Breast Cancer
Keywords: breast cancer
mastectomy
radiotherapy
fractionation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1072 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1
hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
 Radiation: hypofractionation radiotherapy
radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
Active Comparator: 2
conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
 Radiation: conventional fractionation radiotherapy
50Gy/25/f/5w
Open or close this module Outcome Measures
Primary Outcome Measures:
1. locoregional control rate
[ Time Frame: 5 years ]
Secondary Outcome Measures:
1. overall survival
[ Time Frame: 5 years ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Ipsilateral histologically confirmed invasive breast cancer
  • Undergone total mastectomy and axillary dissection
  • T3-4,or axillary lymph nodes positive
  • 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
Open or close this module Contacts/Locations
Central Contact Person: shu-lian wang, M.D.
Telephone: 8610-87788122
Email: wsl20040118@yahoo.com
Study Officials: shu-lian wang, M.D.
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations: China
Cancer Hospital, Chinese Academy of Medical Sciences
[Recruiting]
Beijing, China, 100021
Contact:Principal Investigator: shu-lian wang, M.D.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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