A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
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ClinicalTrials.gov Identifier: NCT00793962 |
Recruitment Status :
Completed
First Posted : November 19, 2008
Last Update Posted : October 11, 2018
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Radiation: hypofractionation radiotherapy Radiation: conventional fractionation radiotherapy | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 810 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | September 2018 |
Arm | Intervention/treatment |
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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
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Radiation: hypofractionation radiotherapy
radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region
Other Name: 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
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Radiation: conventional fractionation radiotherapy
50Gy/25/f/5w
Other Name: radiotherapy |
- locoregional control rate [ Time Frame: 5 years ]ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse
- overall survival [ Time Frame: 5 years ]any death
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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): NCT00793962
China | |
Cancer Hospital, Chinese Academy of Medical Sciences | |
Beijing, China, 100021 |
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 |
Responsible Party: | Shu lian Wang, M.D., Chinese Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00793962 |
Other Study ID Numbers: |
LC2008A06 |
First Posted: | November 19, 2008 Key Record Dates |
Last Update Posted: | October 11, 2018 |
Last Verified: | October 2018 |
breast cancer mastectomy radiotherapy fractionation |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |