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

Primary Purpose

Breast Cancer, Breast Cancer Female, DCIS

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Partial Chest Wall Radiation Therapy
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Stony Brook Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Treatment

Arm Description

Outcomes

Primary Outcome Measures

Breast cancer recurrence
Number of patients with recurrent breast cancer
Acute toxicity
Frequency of radiation-related adverse events
Delayed toxicity
Frequency of radiation-related adverse events
Surgical complications
Number of patients with surgical complications

Secondary Outcome Measures

Full Information

First Posted
June 23, 2022
Last Updated
October 16, 2023
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT05436808
Brief Title
Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No eligible participants identified
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer Female, DCIS, Stage II Breast Cancer, Stage I Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Treatment
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Partial Chest Wall Radiation Therapy
Intervention Description
Patients will receive radiation therapy (30 Gray in 5 fractions) to the affected chest wall, delivered on consecutive days or every other day
Primary Outcome Measure Information:
Title
Breast cancer recurrence
Description
Number of patients with recurrent breast cancer
Time Frame
5 years
Title
Acute toxicity
Description
Frequency of radiation-related adverse events
Time Frame
3 months
Title
Delayed toxicity
Description
Frequency of radiation-related adverse events
Time Frame
5 years
Title
Surgical complications
Description
Number of patients with surgical complications
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Stessin, MD PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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