Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2003 |
Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost in Early Stage Breast Cancer
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.
(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.
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.
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.
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
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