Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alliance for Clinical Trials in Oncology
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted