Comparing One-Week and Two-Week Radiation Therapy for Early Breast Cancer
Sponsor: Weill Medical College of Cornell University
ClinicalTrials ID:NCT06960707
This study is exploring two different schedules of radiation therapy for early breast cancer to see which one works better. One group will receive radiation over one week, while the other group will receive it over two weeks with an extra focused dose. The study will examine side effects, breast appearance, and how well each treatment prevents cancer from returning.
Patient Parameters
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Program Overview
The purpose of this study is to compare two different radiation therapy schedules for early breast cancer. One group will receive radiation over one week, and the other group will receive it over two weeks with an additional focused dose to the tumor area. The study will look at side effects, changes in breast appearance, and how well each treatment controls cancer in the breast. It also aims to find out if the two-week treatment is better at preventing cancer from coming back in the long term.
Description
In this study, participants will be divided into two groups to receive different radiation therapy schedules.
- Group 1 will receive radiation therapy over one week, with a total dose of 2600 cGy divided into 5 sessions. This is the current standard treatment in the UK for early breast cancer.
- Group 2 will receive radiation therapy over two weeks, with a total dose of 3200 cGy divided into 10 sessions, plus an extra focused dose to the tumor area, bringing the total to 3600 cGy. If the tumor area is not visible due to previous surgery, the whole breast will receive 32 Gy without the extra dose.
The study will test if the one-week treatment is as effective as the two-week treatment in terms of side effects, breast appearance, and cancer control at 2 and 5 years. It will also explore if the two-week treatment offers better cancer control at 10 years.
Eligibility Criteria
Inclusion Criteria
- Women who have had a segmental mastectomy.
- If cancer is in one breast, it must be stage pT1-2 and removed with clear margins.
- If cancer is in both breasts, it must be stage pT1-2 and/or stage pTis, all removed with clear margins.
- No signs of cancer in the lymph nodes, or only minimal involvement.
- Ductal carcinoma in situ (DCIS) with clear margins.
- Women who have had cancer in the other breast before can join the study.
Exclusion Criteria
- Previous radiation therapy to the same breast.
- More than 90 days since the last surgery, unless chemotherapy was given after surgery.
- More than 60 days since the last chemotherapy session.
- Male breast cancer.
- Currently receiving treatment for severe autoimmune disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brooklyn Methodist Hospital | 11215 | New York | New York |
| New York Presbyterian Hospital | 11355 | New York | New York |
| New York-Presbyterian Weill Cornell Medical College | 11355 | New York | New York |
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