Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
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ClinicalTrials.gov Identifier: NCT03414970 |
Recruitment Status :
Recruiting
First Posted : January 30, 2018
Last Update Posted : January 11, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | January 17, 2018 | ||||
First Posted Date ICMJE | January 30, 2018 | ||||
Last Update Posted Date | January 11, 2021 | ||||
Actual Study Start Date ICMJE | February 1, 2018 | ||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Rate of breast reconstruction complications [ Time Frame: At 24 months ] Will be tested using a two-sample test of proportions. The test statistic will be calculated and interim analysis for futility will be performed. The primary analyses will be an intent-to-treat analysis where all patients randomized will be included in the analysis and will be analyzed based on the arm they were randomized to regardless of actual radiation schedule received. Due to the random treatment assignment with stratification for the timing of reconstruction and type of reconstruction, it is expected that the baseline patient characteristics, including the planned reconstruction procedures, are roughly balanced across the two treatment arms. A sensitivity analysis stratified by timing and type of reconstruction surgery will be conducted.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer | ||||
Official Title ICMJE | RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction | ||||
Brief Summary | This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects. | ||||
Detailed Description | PRIMARY OBJECTIVES: I. To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. SECONDARY OBJECTIVES: I. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity. II. To evaluate the local and local regional recurrence rate. III. To compare reconstruction complication rates based on reconstruction method (autologous +/- implant versus [vs] implant only) and timing of reconstruction received (immediate vs. intent for delayed). TERTIARY OBJECTIVES: I. To evaluate reconstructed breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation. II. To evaluate reconstructed breast photographic cosmetic scores 24 months after radiation based on the method and timing of reconstruction received. III. To estimate the incidence of arm lymphedema by treatment arm. IV. To compare physical well-being, psychosocial well-being, sexual well-being, satisfaction with breast/nipples/abdomen, and satisfaction with overall outcome between the treatment arms at 24 months after radiation. V. To estimate patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire at 24 months after radiation. VI. To compare the direct and indirect patient costs for radiation therapy by treatment arm. VII. To compare patient reported total health care service utilization 12 months after the completion of radiation. VIII. To compare the economic impact of treatment. IX. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 and determine correlations with a higher likelihood of adverse radiation reactions (radiation sensitivity) and with toxicities. X. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 to determine correlations with secondary endpoints such as local-regional control. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks. GROUP II: Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks. After completion of study, patients are followed up for 5 years. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
880 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 2035 | ||||
Estimated Primary Completion Date | October 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03414970 | ||||
Other Study ID Numbers ICMJE | A221505 NCI-2017-00817 ( Registry Identifier: NCI Clinical Trial Reporting Program ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Alliance for Clinical Trials in Oncology | ||||
Study Sponsor ICMJE | Alliance for Clinical Trials in Oncology | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Alliance for Clinical Trials in Oncology | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |