Trials / Completed
CompletedNCT00068263
3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I and II Breast Carcinoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Radiation Therapy Oncology Group · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.
Detailed description
OBJECTIVES: * Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage I or II breast cancer. * Determine the cosmetic results in patients treated with this regimen. * Determine the complication rates in patients treated with this regimen. * Determine the local control rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery. Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | radiation therapy |
Timeline
- Start date
- 2003-08-01
- Primary completion
- 2005-06-01
- Completion
- 2016-12-01
- First posted
- 2003-09-11
- Last updated
- 2017-01-04
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00068263. Inclusion in this directory is not an endorsement.