NCT00084539

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

Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Radiation therapy

Timeline

• Start date: 2003-11-01
• Primary completion: 2005-11-01
• First posted: 2004-06-11
• Last updated: 2016-03-03

Locations

1 site across 1 country: United States