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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05436808
• Other study ID #: SBU-PCWRT-BREAST
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: July 15, 2022
• Est. completion date: August 2029

Study information

• Verified date: October 2023
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2029
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms
• DCIS
• Stage I Breast Cancer
• Stage II Breast Cancer

Intervention

Radiation:
• Partial Chest Wall Radiation Therapy
Patients will receive radiation therapy (30 Gray in 5 fractions) to the affected chest wall, delivered on consecutive days or every other day

Locations

Country	Name	City	State
United States	Stony Brook Cancer Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast cancer recurrence	Number of patients with recurrent breast cancer	5 years
Primary	Acute toxicity	Frequency of radiation-related adverse events	3 months
Primary	Delayed toxicity	Frequency of radiation-related adverse events	5 years
Primary	Surgical complications	Number of patients with surgical complications	5 years