Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery

• ClinicalTrials.gov Identifier: NCT01413269
• Recruitment Status: Completed
• First Posted: August 10, 2011
• 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: August 9, 2011
• First Posted Date: August 10, 2011
• Last Update Posted Date: October 11, 2018
• Study Start Date: June 2010
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2011)

in-breast recurrence rate [ Time Frame: 5 year ]

evidence of ipsilateral breast local recurrence confirmed by histology

• Original Primary Outcome Measures: Same as current

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

• regional node recurrence rate [ Time Frame: 5 year ]
  ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology.
• disease-free survival [ Time Frame: 5 year ]
  locoregional relapse, distant relapse, death
• overall survival [ Time Frame: 5 year ]
  any death
• acute toxicity [ Time Frame: 6 months ]
  radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria
• late complication [ Time Frame: 3 -10 year ]
  breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction

Original Secondary Outcome Measures (submitted: August 9, 2011)

• regional node recurrence rate [ Time Frame: 5 year ]
  ipsilater axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examinztion,image evaluation or histology.
• disease-free survival [ Time Frame: 5 year ]
• overall survival [ Time Frame: 5 year ]
• acute toxicity [ Time Frame: 6 months ]
  radiation dermititis and radiation pneumonitis evaluated and graded by CTC3.0 criteria
• late complication [ Time Frame: 3 -10 year ]
  breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery
• Official Title: Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery
• Brief Summary: Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.
• Detailed Description: Not Provided
• 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: radiotherapy

one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.

the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.

Study Arms

• Experimental: hypofractionation radiotherapy
  irradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.
  Intervention: Radiation: radiotherapy
• Active Comparator: conventional fractionation radiotherapy
  irradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
  Intervention: Radiation: radiotherapy

• Publications *: Wang SL, Fang H, Hu C, Song YW, Wang WH, Jin J, Liu YP, Ren H, Liu J, Li GF, Du XH, Tang Y, Jing H, Ma YC, Huang Z, Chen B, Tang Y, Li N, Lu NN, Qi SN, Yang Y, Sun GY, Liu XF, Li YX. Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China. J Clin Oncol. 2020 Nov 1;38(31):3604-3614. doi: 10.1200/JCO.20.01024. Epub 2020 Aug 11.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 29, 2016): 720
• Original Estimated Enrollment (submitted: August 9, 2011): 630
• Actual Study Completion Date: September 2018
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. KPS>=60
2. histology confirmed invasive breast cancer
3. received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
4. surgical margins negative
5. primary tumor ≤5cm in the largest diameter
6. no internal mammary node or supraclavicular node metastases or distant metastasis
7. can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
8. for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
9. for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
10. patients signed written inform consent form

Exclusion Criteria:

1. ductal carcinoma in situ
2. prior neoadjuvant chemotherapy
3. prior breast cancer history
4. bilateral breast cancer
5. pregnant or during lactation
6. prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
7. active collagen vascular disease
8. prior neoadjuvant hormone therapy
9. immediate ipsilateral breast reconstruction

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 70 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: NCT01413269
• Other Study ID Numbers: CH-BC-013
• 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: Ye-xiong Li, 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

• Study Chair: ye-xiong Li, M.D.; Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Principal Investigator: Shu-lian Wang, M.D.; Cancer Institute and Hospital, Chinese Academy of Medical Sciences

• PRS Account: ChineseAMS
• Verification Date: October 2018