This trial is active, not recruiting.

Condition breast cancer
Treatments radiation therapy
Phase phase 2
Sponsor Fox Chase Cancer Center
Collaborator National Cancer Institute (NCI)
Start date November 2003
End date December 2015
Trial size 78 participants
Trial identifier NCT00084539, 03026, CDR0000365456, P30CA006927


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Radiation Therapy Daily 5 days per week for 4 weeks 45 Gy in 20 fractions whole breast 56 Gy in 20 fractions to boost volume
radiation therapy
radiation therapy

Primary Outcomes

Acute toxicity by CTCAE at 6 weeks
time frame: 6 weeks

Secondary Outcomes

Quality of life as measured by the Breast Cancer Treatment Outcome Scale (BCTOS) every 6 months for 5 years
time frame: every 6 months for 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed carcinoma of the breast - Invasive or in-situ disease - Stage Tis, T1, or T2 (AJCC stage 0, I, or II) disease - Treated with breast-conserving surgery within the past 8 weeks - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Not specified Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 75,000/mm^3 Hepatic - Not specified Renal - Not specified Other - No other malignancy within the past 2 years except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer - No active systemic lupus - No history of scleroderma - No other medical or psychiatric condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No more than 6 weeks since prior adjuvant systemic chemotherapy - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to the breast Surgery - See Disease Characteristics

Additional Information

Official title Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer
Principal investigator Penny Anderson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Fox Chase Cancer Center.