Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer

Sponsor

Stony Brook University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05436808

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The standard treatment for breast cancer when cancer cells were found near or within the margins of the tissue that is removed during breast surgery, is radiation of the entire chest wall. This may be considered overtreatment since the only reason for doing so is that cancer cells were near or in the margins of the breast tissue that was removed. In this study, the amount of radiation treatment will be limited to the area where the remaining cancer cells were found after surgery.

The purpose of this study is to find out if partial chest wall radiation therapy is as good as whole chest wall radiation therapy in reducing the risk of breast cancer cancer coming back.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Cancer Female DCIS Stage II Breast Cancer Stage I Breast Cancer	Radiation: Partial Chest Wall Radiation Therapy	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Pilot Study of Partial Chest Wall Radiation Therapy (PCWRT) for Positive or Close Margins After Modified Radical Mastectomy for Lymph Node-Negative Breast Cancer

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiation Treatment	Radiation: Partial Chest Wall Radiation Therapy Patients will receive 30 Gray in 5 fractions delivered on consecutive days or every other day

Arm

Intervention/Treatment

Experimental: Radiation Treatment

Radiation: Partial Chest Wall Radiation Therapy

Patients will receive 30 Gray in 5 fractions delivered on consecutive days or every other day

Outcome Measures

Primary Outcome Measures

Breast cancer recurrence [5 years]
Number of patients with recurrent breast cancer
Acute toxicity [3 months]
Frequency of radiation-related adverse events
Delayed toxicity [5 years]
Frequency of radiation-related adverse events
Surgical complications [5 years]
Number of patients with surgical complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

DCIS or stage T1 or T2 invasive breast cancer, lymph node negative
Must have undergone mastectomy
Presence of cancer cells on or close to surgical margins
Negative pregnancy test for women
Must receive radiation at Stony Brook University Hospital

Exclusion Criteria

Received prior radiation to are to be irradiated

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stony Brook Cancer Center	Stony Brook	New York	United States	11794

Sponsors and Collaborators

Stony Brook University

Investigators

Principal Investigator: Alexander Stessin, MD PhD, Stony Brook University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexander Stessin, Associate Professor of Medicine, Stony Brook University

ClinicalTrials.gov Identifier:

NCT05436808

Other Study ID Numbers:

SBU-PCWRT-BREAST

First Posted:

Jun 29, 2022

Last Update Posted:

Jun 29, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jun 29, 2022