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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793962
First Posted: November 19, 2008
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shu lian Wang, Chinese Academy of Medical Sciences
November 17, 2008
November 19, 2008
July 24, 2017
June 2008
May 2016   (Final data collection date for primary outcome measure)
locoregional control rate [ Time Frame: 5 years ]
ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse
locoregional control rate [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00793962 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 5 years ]
any death
overall survival [ Time Frame: 5 years ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Active, not recruiting
810
May 2021
May 2016   (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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00793962
LC2008A06
Yes
Not Provided
Not Provided
Shu lian Wang, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Principal Investigator: shu-lian wang, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Chair: Ye-xiong Li, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
July 2017

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