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A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Shu lian Wang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00793962
First received: November 17, 2008
Last updated: January 28, 2014
Last verified: January 2014

November 17, 2008
January 28, 2014
June 2008
October 2015   (final data collection date for primary outcome measure)
locoregional control rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00793962 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Radiation: hypofractionation radiotherapy
    radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
    Other Name: radiotherapy
  • Radiation: conventional fractionation radiotherapy
    50Gy/25/f/5w
    Other Name: radiotherapy
  • Experimental: hypofractionation radiotherapy
    breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
    Intervention: Radiation: hypofractionation radiotherapy
  • Active Comparator: conventional fractionation radiotherapy
    breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
    Intervention: Radiation: conventional fractionation radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1072
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ipsilateral histologically confirmed invasive breast cancer
  • Undergone total mastectomy and axillary dissection
  • T3-4,or >=4 positive axillary lymph nodes
  • Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
  • Written,informed consent
  • cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
  • no supraclavicular or internal mammary nodes metastases
  • no distant metastases
  • enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
  • enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.

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
  • bilateral breast cancer
  • immediate or delayed ipsilateral breast cancer reconstruction
Female
18 Years to 75 Years
No
Contact: shu-lian wang, M.D. 8610-87788122 wsl20040118@yahoo.com
China
 
NCT00793962
LC2008A06
Yes
Shu lian Wang, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: shu-lian wang, M.D. Cancer Hospital, Chinese Academy of Medical Sciences
Study Chair: Ye-xiong Li, M.D. Cancer Hospital,Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP