Accelerated Radiation Therapy for Breast Cancer and Nearby Lymph Nodes

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40

ClinicalTrials ID:NCT02917421

This study is for patients with newly diagnosed breast cancer who need radiation therapy after chemotherapy and surgery. It explores a faster radiation treatment to the breast and nearby lymph nodes.

Patient Parameters

Parameter	Options

Program Overview

This study is designed for patients with newly diagnosed breast cancer who have undergone chemotherapy and surgery. It aims to test a faster radiation therapy approach to treat the breast and nearby lymph nodes. The treatment is divided into two groups: one group will receive radiation to the breast and chest area, while the other group will also receive radiation to additional lymph nodes. The entire treatment will be completed in three weeks, and patients will be monitored regularly for five years after treatment.

Description

The study involves two groups of patients.

Group 1: Patients will receive radiation to the breast and chest wall. This involves a specific type of radiation therapy called 3D-CRT or IMRT, delivered in 15 sessions over three weeks. Patients who have had a segmental mastectomy will receive an additional boost of radiation to the original tumor area, unless they have had breast reconstruction.
Group 2: Patients will receive radiation to the breast, chest wall, and certain lymph nodes near the collarbone and underarm. This also involves 3D-CRT or IMRT, delivered in 15 sessions over three weeks.

After completing the treatment, all patients will have a follow-up appointment three months later and then yearly for the next five years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

Women older than 18 years with Stage I-III breast cancer.
Have completed chemotherapy and breast surgery.
Original breast cancer was confirmed by biopsy and removed with clear margins.
Have had either a segmental mastectomy or full mastectomy, with a negative sentinel node biopsy or removal of at least 6 lymph nodes.
Must be able to understand and agree to sign a consent form.

Exclusion Criteria

Have had previous radiation therapy to the same breast or lymph node area.
Have active connective tissue disorders like lupus or scleroderma that require treatment.
Are pregnant or breastfeeding.
Are receiving chemotherapy, except for specific anti-HER2 therapies.
Have inadequate lymph node removal if the sentinel node is positive.
Have more than 5 lymph nodes involved, as they may need additional radiation therapy.

Locations

FACILITY	ZIP	CITY	STATE
New York Presbyterian Hospital - Queens	10065	New York	New York
Weill Cornell Medical College	10065	New York	New York
Brooklyn Methodist Hospital - NewYork Presbyterian	11215	New York	New York

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