Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acute toxicity by CTCAE at 6 weeks
Safety Issue:
Yes
Principal Investigator
Penny Anderson, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000365456
NCT ID:
NCT00084539
Start Date:
November 2003
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- breast cancer in situ
- Breast Neoplasms
Name | Location |
|---|---|
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
