Hypofractionated vs. Conventional Regional Nodal Radiation Therapy for Patients With Invasive Breast Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. To compare the risk of developing lymphedema, defined as a 10% difference in volume between the affected and unaffected arm, within 24 months of regional nodal irradiation (RNI) between patients assigned to short versus standard RNI. SECONDARY OBJECTIVES: I. To compare the max...

PRIMARY OBJECTIVES: I. To compare the risk of developing lymphedema, defined as a 10% difference in volume between the affected and unaffected arm, within 24 months of regional nodal irradiation (RNI) between patients assigned to short versus standard RNI. SECONDARY OBJECTIVES: I. To compare the maximum standardized difference in arm volume between the affected arm and the unaffected arm within 24 months after completion of RNI between the two treatment arms. II. To compare maximal acute (within 6 weeks of treatment) and late (more than 6 weeks after treatment) skin and soft tissue toxicities using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v)4.0 scale between patients assigned to short versus standard RNI. III. To compare patient-reported arm and shoulder function for the two treatment arms using the 9-item Disabilities Arm Shoulder and Hand questionnaire (QuickDASH-9). IV. To compare patient quality of life for the two treatment arms using EQ-5D-3L and the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue SF 6a. V. To compare the peripheral blood cytokine profile at the end of radiation between patients assigned to short versus standard RNI. VI. To evaluate the effect of the peripheral blood cytokine profile at the end of radiation on developing lymphedema. VII. To evaluate the effect of homocysteine levels prior to radiation on developing lymphedema. VIII. To evaluate time to locoregional recurrence, time to distant metastasis, disease-free survival and overall survival for patients assigned to short versus standard RNI. IX. To evaluate the effect of lipid profiles prior to radiation on the time to locoregional recurrence. X. To evaluate if deoxyribonucleic acid (DNA) repair capacity contributes to the presence of acute radiation related toxicity and patient-reported quality of life decrements including fatigue and arm and shoulder symptoms. XI. To evaluate changes in echocardiography global longitudinal strain measurements and cardiac serum biomarkers, based on measurements performed before and after radiation therapy (RT), in patients assigned to short versus standard RNI. XII. In a separate cohort of 30 patients who will receive RNI before surgery, to collect information on number of patients developing lymphedema within 24 months of RNI on reconstructive complications, and on patient reported quality of life, in those assigned to short versus standard RNI. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo hypofractionated RNI in 15 fractions 5 consecutive days a week for 3 weeks. ARM II: Patients undergo standard RNI in 25 fractions 5 consecutive days a week for 5 weeks. In both arms, patients undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI. PATIENT EVALUATION: Patients participating in the trial will have their arm measured prior to radiation, during the final week of radiation and when they return for follow up visits. Patients will be checked for any arm swelling that may develop. Patients will also fill out questionnaires before treatment and when they return for follow up visits. Patients return 3 and 6 months after radiation, then every 6 months through two and a half years after radiation and then on a yearly basis until ten and a half years after finishing radiation. At some of the follow up visits, we measure arm volume and ask participants to complete questionnaires.

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