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

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:
NCT01413269
First received: August 9, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • in-breast recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    evidence of ipsilateral breast local recurrence confirmed by histology


Secondary Outcome Measures:
  • regional node recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • acute toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria

  • late complication [ Time Frame: 3 -10 year ] [ Designated as safety issue: Yes ]
    breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction


Estimated Enrollment: 630
Study Start Date: June 2010
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
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.


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413269

Locations
China
Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: shu-lian Wang, M.D.    10-87787625    wsl20040118@yahoo.com   
Contact: ye-xiong Li, M.D.    10-87788860    yexiong@yahoo.com   
Principal Investigator: Shu-lian Wang, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Study Chair: ye-xiong Li, M.D. Cancer Hospital, Chinese Academy of Medical Sciences
Principal Investigator: Shu-lian Wang, M.D. Cancer Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Shu lian Wang, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01413269     History of Changes
Other Study ID Numbers: CH-BC-013
Study First Received: August 9, 2011
Last Updated: January 28, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
breast cancer patients
breast conservation surgery
hypofractionated radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014