Study on Shortened Radiation Therapy After Mastectomy to Prevent Cancer Return in Stage IIa-IIIa Breast Cancer Patients
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT03414970
This clinical trial is exploring whether a shorter course of radiation therapy after mastectomy can effectively prevent cancer from returning in patients with Stage IIa-IIIa breast cancer. The study compares traditional radiation schedules with a shorter, higher-dose approach to see if it reduces side effects and complications.
Patient Parameters
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Program Overview
The purpose of this study is to determine if a shorter course of radiation therapy, known as hypofractionated radiation, can prevent the return of breast cancer in patients who have had a mastectomy for Stage IIa-IIIa breast cancer. This type of radiation delivers higher doses over a shorter period, which may kill more remaining cancer cells and cause fewer side effects. Patients will be randomly assigned to receive either the standard radiation schedule or the shorter hypofractionated schedule. The study will follow patients for five years to monitor outcomes.
Description
The main goal of this study is to see if the rate of complications from breast reconstruction surgery is similar between the standard and shorter radiation schedules 24 months after treatment.
Other goals include:
- Checking for any immediate or long-term side effects from the radiation.
- Measuring how often the cancer returns in the breast area.
- Comparing reconstruction complications based on the type and timing of reconstruction surgery.
- Evaluating the cosmetic appearance of the reconstructed breast after radiation.
- Assessing the occurrence of arm swelling (lymphedema) by treatment group.
- Comparing physical, emotional, and sexual well-being, as well as satisfaction with the breast reconstruction, between the two treatment groups.
- Estimating patient satisfaction with the trial using a questionnaire.
- Comparing the costs of radiation therapy and overall healthcare use between the groups.
- Analyzing genetic factors that might affect radiation sensitivity and side effects.
Participants will be randomly assigned to one of two groups:
- Group I: Standard radiation therapy daily for 5-6 weeks.
- Group II: Shortened hypofractionated radiation therapy daily for 3-4 weeks.
After completing the study, patients will be followed up for five years to monitor their health and any recurrence of cancer.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with invasive breast cancer of specific types (ductal, lobular, mammary, medullary, or tubular).
- Cancer staged as IIa-IIIa according to specific criteria, with no spread to distant organs.
- No previous radiation therapy to the chest, neck, or armpit area.
- No history of cancer in the same breast or invasive cancer in the opposite breast.
- No active autoimmune diseases like lupus or scleroderma.
- Clear surgical margins after mastectomy, meaning no cancer cells at the edge of the removed tissue.
- No significant complications after mastectomy that required unplanned surgery or hospital admission.
- Radiation oncologist plans to treat all necessary areas and follow specific guidelines.
- Must have had or plan to have breast reconstruction within 18 months after radiation.
- Radiation treatment must start within the specified timeframe.
- If using a tissue expander, it must be fluid-filled during radiation.
- For diabetic patients, a recent hemoglobin A1C test is required.
- No other serious medical conditions that limit life expectancy to less than five years.
- No other cancers within the past five years, except for certain skin cancers or cervical carcinoma in situ.
- Negative pregnancy test for women of childbearing potential before starting the study.
- Women must agree to use birth control or abstain from sex during radiation therapy.
- Good overall health with an ECOG performance status of 0 or 1.
- Must be able to read and understand English or French (for Canadian participants) to complete study questionnaires.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
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