Trials / Active Not Recruiting

Active Not RecruitingNCT04871516

Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer

A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 103 (actual)

Sponsor: Rutgers, The State University of New Jersey · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.

Detailed description

PRIMARY OBJECTIVE: I. To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery (BCS) and treated with pre-operative radiation boost at 1 month after end of whole breast radiation is no worse than the rates in the current standard of care (6-20%). SECONDARY OBJECTIVE: I. To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI). TERTIARY/EXPLORATORY OBJECTIVES: I. To measure the acute and late radiation related toxicities such as radiation dermatitis, telangiectasia and fibrosis in this cohort of patients. II. To measure the pre-operative boost clinical target volume (CTV) and compare to the post-op CTV volume that would have been contoured as CTV if the boost was to be delivered post-operatively. III. To measure the incidence of fair/poor patient reported cosmetic outcome using the Breast Cancer Treatment Outcomes Scale (BCTOS) cosmetic scale. IV. To study the cancer biology before and after radiation treatment. OUTLINE: Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, and 24 months

Conditions

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Boost	Undergo radiation therapy boost
PROCEDURE	Therapeutic Surgical Procedure	Undergo standard surgery
RADIATION	Whole Breast Irradiation	Undergo standard WBI
OTHER	Breast MRI	A baseline breast MRI

Timeline

Start date: 2021-05-18
Primary completion: 2027-12-05
Completion: 2028-01-31
First posted: 2021-05-04
Last updated: 2026-01-22

Locations

11 sites across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT04871516. Inclusion in this directory is not an endorsement.