3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Radiation: brachytherapyRadiation: 3-dimensional conformal radiation therapy
- Registration Number
- NCT00802711
- Lead Sponsor
- Cancer Trials Ireland
- Brief Summary
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer.
PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage I or stage II breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* To compare the rate of successfully delivered accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brachytherapy in women with stage I or II invasive ductal carcinoma of the breast.
* To establish potential patient participation in ongoing phase III clinical trials (e.g., NSABP-B-39, GEC-ESTRO, RAPID, MPORT, and IRMA) that compare APBI to standard whole-breast irradiation.
Secondary
* To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE version 3.0.
* To assess long-term radiation-induced toxicity in these patients as assessed by RTOG-EORTC scale.
* To assess the incidence and type of adverse events in the breast of these patients.
* To assess the incidence and type of procedure-related complications in these patients.
* To determine local control and pattern of recurrence in these patients.
* To determine disease-free survival (distant and recurrence-free survival) of these patients.
* To determine overall survival of these patients.
* To assess cosmesis in these patients as assessed by the Breast Cancer Treatment Outcome and RTOG scales.
* To assess treatment-related symptoms in these patients as assessed by the Breast Cancer Treatment Outcome scale.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with a lumpectomy cavity/whole breast ratio 25-30% are assigned to treatment in arm II.
* Arm I: Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires at baseline, on the last day of treatment, at 4 and 24 weeks after completion of treatment, and then annually for 3 years.
After completion of study treatment, patients are followed periodically for at least 5 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II brachytherapy Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. Arm I 3-dimensional conformal radiation therapy Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Rate of successfully delivered accelerated partial breast irradiation Never established as trial terminated
- Secondary Outcome Measures
Name Time Method Disease-free survival (distant and recurrence-free survival) Never established as trial terminated Acute radiation-induced toxicity as assessed by NCI CTCAE v3.0 Never established as trial terminated Long-term radiation-induced toxicity as assessed by RTOG-EORTC scale Never established as trial terminated Local control and pattern of recurrence Never established as trial terminated Quality of life (e.g., cosmesis and treatment-related symptoms) as assessed by the Breast Cancer Treatment Outcome and RTOG scales Never established as trial terminated Incidence and type of procedure-related complications Never established as trial terminated Incidence and type of adverse events in the breast Never established as trial terminated Overall survival Never established as trial terminated
Trial Locations
- Locations (1)
Saint Luke's Radiation Oncology Network
🇮🇪Dublin, Ireland