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

• ClinicalTrials.gov Identifier: NCT00793962
• Recruitment Status: Completed
• First Posted: November 19, 2008
• Last Update Posted: October 11, 2018
• Sponsor: Chinese Academy of Medical Sciences
• Information provided by (Responsible Party): Shu lian Wang, Chinese Academy of Medical Sciences

Tracking Information

• First Submitted Date: November 17, 2008
• First Posted Date: November 19, 2008
• Last Update Posted Date: October 11, 2018
• Study Start Date: June 2008
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2017)

locoregional control rate [ Time Frame: 5 years ]

ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse

• Original Primary Outcome Measures (submitted: November 17, 2008): locoregional control rate [ Time Frame: 5 years ]

Current Secondary Outcome Measures (submitted: July 20, 2017)

overall survival [ Time Frame: 5 years ]

any death

• Original Secondary Outcome Measures (submitted: November 17, 2008): overall survival [ Time Frame: 5 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer

Intervention

• 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

Study Arms

• 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

Publications *

• Yang J, Qi SN, Fang H, Song YW, Jin J, Liu YP, Wang WH, Yang Y, Tang Y, Ren H, Chen B, Lu NN, Tang Y, Li N, Jing H, Wang SL, Li YX. Cost-effectiveness of postmastectomy hypofractionated radiation therapy vs conventional fractionated radiation therapy for high-risk breast cancer. Breast. 2021 Aug;58:72-79. doi: 10.1016/j.breast.2021.04.002. Epub 2021 Apr 19.
• Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 29, 2016): 810
• Original Estimated Enrollment (submitted: November 17, 2008): 1072
• Actual Study Completion Date: September 2018
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00793962
• Other Study ID Numbers: LC2008A06
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Shu lian Wang, Chinese Academy of Medical Sciences
• Original Responsible Party: Cancer Hospital, Chinese Academy of Medical Sciences
• Current Study Sponsor: Chinese Academy of Medical Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: ChineseAMS
• Verification Date: October 2018