Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT06129747
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy — RADIATION
    Weeks 1, 2 and 3 * Weeks 1, 2 and 3 will include 5 days of treatment. * One radiation treatment to breast on each of the 5 days. Each radiation treatment session will last a 30 minutes.

Study Details

The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.

Key Dates

Start date
Nov 30, 2023
Status verified
May 2026
Primary completion
Aug 9, 2029
Completion
Aug 9, 2029

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation Therapy(RT)
    There will be one treatment cohort. Radiation therapy will be delivered daily for 15 daily fractions, 2.67Gy per fraction, delivered using a 3-D or IMRT(Intensity Modulate Radiation Therapy) plan. For participants with high-risk features deemed by the radiation oncologist who would otherwise be a candidate for a boost (age \<50, high grade, poor biology, close margins), 48 Gy delivered in fifteen fractions of 3.2 Gy is allowed.

Primary Outcome Measure

Treatment-related adverse events as graded by CTCAE criteria [ Time Frame: 1 year from the completion of re-irradiation ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44195
Rahul Tendulkar, MD
[email protected]
866-223-8100
Rahul Tendulkar, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-5065-

Find similar trials in Cleveland, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center· Cleveland, OHUniversity Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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