Partial Chest Wall Radiation Therapy After Surgery for Ly... | NCT05436808

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

NCT05436808

Sponsor

Stony Brook University

Status

Withdrawn

Last Update Posted

Oct 18, 2023Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Breast Cancer
Breast Cancer Female
DCIS
Stage II Breast Cancer
Stage I Breast Cancer

Interventions

Partial Chest Wall Radiation Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No eligible participants identified

Expanded Access Info

Start Date

Jul 15, 2022Actual

Primary Completion Date

Aug 2024Estimated

Completion Date

Aug 2029Estimated

First Submitted Date

Jun 23, 2022

First Submission Date that Met QC Criteria

Jun 23, 2022

First Posted Date

Jun 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2023

Last Update Posted Date

Oct 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiation Treatment	Experimental		Radiation: Partial Chest Wall Radiation Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Partial Chest Wall Radiation Therapy	Radiation	Patients will receive radiation therapy (30 Gray in 5 fractions) to the affected chest wall, delivered on consecutive days or every other day

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander Stessin, MD PhD	Stony Brook University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stony Brook Cancer Center		Stony Brook	New York	11794	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D002285	Carcinoma, Intraductal, Noninfiltrating

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided