NCT00802711

3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer

Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cancer Trials Ireland · Network
• Sex: Female
• Age: 50 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	3-dimensional conformal radiation therapy	Given twice a day for 10 fractions
RADIATION	brachytherapy	Given twice a day for 10 fractions

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-12-05
• Last updated: 2026-04-13

Locations

1 site across 1 country: Ireland