Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00084539
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer.

Secondary

* Determine the long-term cosmetic result and quality of life of patients treated with this regimen.

* Determine the long-term local control in patients treated with this regimen.

OUTLINE: Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks.

Quality of life is assessed within 1 month of starting radiotherapy, at 6 weeks after completion of radiotherapy, and then every 6 months for 5 years.

Patients are followed at 6 weeks and then every six months for 5 years.

PROJECTED ACCRUAL: A total of 37-74 patients will be accrued for this study.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-06-10
• Study First Submitted QC: 2004-06-10
• Study First Posted: 2004-06-11
• Primary Completion: 2005-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acute toxicity by CTCAE at 6 weeks	6 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by the Breast Cancer Treatment Outcome Scale (BCTOS) every 6 months for 5 years	every 6 months for 5 years

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States