Houston, Texas 77030


Purpose:

Investigators are conducting a clinical trial to compare two different treatment schedules for women who need radiation therapy to their lymph nodes as part of their breast cancer treatment. Eligible patients will be randomly assigned to either a traditional radiation therapy schedule, which takes approximately 6 weeks to complete, or to an innovative, newer radiation therapy schedule, which takes approximately 4 weeks to complete. The available evidence suggests that both the traditional and the newer radiation schedules are highly effective for preventing recurrence. The main purpose of the trial is to see if the newer radiation treatment schedule will lower the risk of developing arm swelling, also known as lymphedema, after radiation treatment. We will also be studying the impact of the innovative, shorter, treatment on patient-reported arm function and quality of life.


Study summary:

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.


Criteria:

Inclusion Criteria: - POSTOPERATIVE RADIATION THERAPY: Radiation oncologist recommends radiation treatment to the supraclavicular and infraclavicular fossa (i.e. RNI) - POSTOPERATIVE RADIATION THERAPY: Pathologically-confirmed invasive breast cancer; if patients undergo upfront surgery, the pathologic stage must be T0-T3, N0-N2a or N3a; if patients receive neoadjuvant chemotherapy prior to surgery, the clinical stage must be T0-T3, N0-N2a or N3a - POSTOPERATIVE RADIATION THERAPY: Treatment with mastectomy or segmental mastectomy and axillary evaluation (sentinel node evaluation, axillary sampling, or axillary lymph node dissection); if the patient has T0 disease, breast surgery is not required - POSTOPERATIVE RADIATION THERAPY: Documentation of arm volume measurement by perometer prior to axillary surgery - POSTOPERATIVE RADIATION THERAPY: If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer - POSTOPERATIVE RADIATION THERAPY: Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy - PREOPERATIVE RADIATION THERAPY: Surgeon and radiation oncologist recommend preoperative radiation therapy - PREOPERATIVE RADIATION THERAPY: Pathologically-confirmed invasive breast cancer. The clinical stage must be T0-T3, N0-N3a - PREOPERATIVE RADIATION THERAPY: Planned treatment with mastectomy and axillary evaluation (sentinel node evaluation, axillary sampling, or axillary lymph node dissection) - PREOPERATIVE RADIATION THERAPY: If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer Exclusion Criteria: - Pathologic or clinical evidence for a stage T4 breast cancer - Pathologic or clinical evidence for a stage N2b, N3b, or N3c breast cancer (supraclavicular, or internal mammary lymph node involvement) - Clinical or pathologic evidence for distant metastases - Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast - Current diagnosis of bilateral breast cancer - History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast - Patient is pregnant


NCT ID:

NCT02912312


Primary Contact:

Principal Investigator
Karen Hoffman, MD
M.D. Anderson Cancer Center

Karen Hoffman, MD
Phone: 713-563-2331
Email: khoffman1@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Karen E. Hoffman, MD
Phone: 713-563-2331

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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