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Sponsored by: |
Chinese Academy of Medical Sciences |
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Information provided by: | Chinese Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00793962 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Radiation: hypofractionation radiotherapy Radiation: conventional fractionation radiotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-Risk Breast Cancer |
Estimated Enrollment: | 1072 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | October 2015 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
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Radiation: hypofractionation radiotherapy
radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
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2: Active Comparator
conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region
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Radiation: conventional fractionation radiotherapy
50Gy/25/f/5w
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: shu-lian wang, M.D. | 8610-87788122 | wsl20040118@yahoo.com |
China | |
Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting |
Beijing, China, 100021 | |
Principal Investigator: shu-lian wang, M.D. |
Principal Investigator: | shu-lian wang, M.D. | Cancer Hospital, Chinese Academy of Medical Sciences |
Responsible Party: | Cancer Hospital, Chinese Academy of Medical Sciences ( Cancer Hospital, Chinese Academy of Medical Sciences ) |
Study ID Numbers: | LC2008A06 |
Study First Received: | November 17, 2008 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00793962 |
Health Authority: | China: Ethics Committee |
breast cancer mastectomy radiotherapy fractionation |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |