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ACTIVE NOT RECRUITING

NCT03414970

PHASE3

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

Official title: RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

898

Start Date

2018-03-12

Completion Date

2035-08

Last Updated

2026-02-24

Healthy Volunteers

Conditions

Ductal Breast Carcinoma Invasive Breast Carcinoma Lobular Breast Carcinoma Medullary Breast Carcinoma Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Tubular Breast Carcinoma

Interventions

RADIATION

Radiation Therapy

Undergo RT

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated RT

Inclusion Criteria: * Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); patients with metaplastic breast cancer are not eligible * Patients will be staged according to the TNM staging system * For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status * For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients; patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy; cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes * Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy; all patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible. N1mic patients are eligible. * No prior therapeutic radiation therapy to the chest, neck or axilla; prior radioactive oral iodine is permitted * No prior history of ipsilateral breast cancer (invasive disease or ductal breast carcinoma in situ \[DCIS\]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed * No history of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed * No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis * Negative inked histologic margins from mastectomy pathology (no invasive cells at margin). Patients with DCIS at margin are eligible. * No significant post mastectomy complications in the ipsilateral breast requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable * Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended) * Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements * Radiation oncologist is NOT planning to utilize a chest wall/scar boost * Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 18 months after radiation * Treating physician and patient must plan to start radiation treatment within the timeframes specified in protocol. * If a tissue expander is utilized it needs to be a fluid filled expander, NO air expander (unless completely deflated) during radiation therapy * For patients with diabetes, hemoglobin A1C test must have been performed =\< 90 days prior to registration * No co-existing medical conditions with life expectancy \< 5 years * No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix * Negative pregnancy test (serum or urine HCG) in women of child-bearing potential ≤ 7 days prior to registration. Patients who have received a bilateral tubal ligation still require a negative pregnancy test for eligibility. A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months * Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy * Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1 * Patients must be able to read and comprehend English, in order to be able to complete study questionnaires; however, patients participating through Canadian Cancer Trials Group (CCTG) institutions who can read and comprehend French are eligible

Locations (859)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

City of Hope Corona

Corona, California, United States

UC Irvine Health Cancer Center-Newport

Costa Mesa, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Epic Care-Dublin

Dublin, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Fresno Cancer Center

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

Kaiser Permanente - Sacramento

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

University of Colorado Hospital

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

Cancer Center of Colorado at Sloan's Lake