Study on Hypofractionated vs. Standard Radiation Therapy for Early Breast Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT01266642
This clinical trial is comparing two types of radiation therapy to see which is more effective in treating patients with ductal breast carcinoma in situ or early invasive breast cancer. The study aims to find out if giving higher doses of radiation over a shorter period can kill more cancer cells with fewer side effects.
Patient Parameters
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Program Overview
This study is testing two different ways of giving radiation therapy to patients with early-stage breast cancer. One method uses higher doses of radiation over a shorter time (hypofractionated radiation therapy), while the other uses standard doses over a longer period. The goal is to see which method is better at controlling cancer and has fewer side effects. Patients will be randomly assigned to one of the two treatment groups and will be followed up for five years to monitor their outcomes.
Description
The main goal of this study is to compare how patients feel about the appearance of their breast after receiving either hypofractionated or standard radiation therapy. This will be measured using a special scale at different times over five years. The study will also look at how doctors rate the appearance of the breast and compare it to the patients' ratings.
Other goals include checking how often the cancer comes back in the same breast, how patients feel about their breast function and pain, and any side effects on the skin and tissue. The study will also explore if factors like breast size or the amount of radiation affect the appearance of the breast.
Patients will be randomly assigned to one of two groups:
- Group 1 will receive higher doses of radiation over about three weeks.
- Group 2 will receive standard doses of radiation over about five weeks.
After treatment, patients will have follow-up visits at six months and then once a year for five years to check on their health and the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with ductal carcinoma in situ or early invasive breast cancer.
- Have had breast-conserving surgery with no cancer cells at the edges of the removed tissue.
- Aged 40 years or older.
- Female.
- Plan to treat only the whole breast with radiation, not the lymph nodes.
- If previously treated for another cancer, must have completed treatment and be cancer-free.
- Must join the study within 12 weeks after surgery or last chemotherapy session.
Exclusion Criteria
- Have stage T3 or T4 breast cancer.
- Have cancer in four or more lymph nodes or in certain other lymph nodes.
- Have cancer that has spread to other parts of the body.
- Have had breast cancer before in either breast.
- Have cancer in both breasts now.
- Have had radiation therapy to areas that might overlap with the breast.
- Not fluent in English or Spanish.
- Pregnant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| UF Cancer Center at Orlando Health | 32806 | Orlando | Florida |
| MD Anderson in The Woodlands | 77384 | Conroe | Texas |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
| MD Anderson West Houston | 77079 | Houston | Texas |
| MD Anderson League City | 77573 | League City | Texas |
| MD Anderson in Sugar Land | 77478 | Sugar Land | Texas |
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