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

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ClinicalTrials.gov Identifier: NCT01413269
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Shu lian Wang, Chinese Academy of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: radiotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2010
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. in-breast recurrence rate [ Time Frame: 5 year ]
    evidence of ipsilateral breast local recurrence confirmed by histology


Secondary Outcome Measures :
  1. 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.

  2. disease-free survival [ Time Frame: 5 year ]
    locoregional relapse, distant relapse, death

  3. overall survival [ Time Frame: 5 year ]
    any death

  4. acute toxicity [ Time Frame: 6 months ]
    radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria

  5. late complication [ Time Frame: 3 -10 year ]
    breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413269


Locations
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China, Beijing
Beijing hospital
Beijing, Beijing, China, 100730
China, Shanghai
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
China, Zhejiang
Zhejiang Cancer Hospital
Hang-zhou, Zhejiang, China, 310022
China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shu lian Wang, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01413269    
Other Study ID Numbers: CH-BC-013
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by Shu lian Wang, Chinese Academy of Medical Sciences:
breast cancer patients
breast conservation surgery
hypofractionated radiotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases