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

Breast Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00802711
• Study type: Interventional
• Source: Cancer Trials Ireland
• Status: Terminated
• Phase: N/A
• Start date: October 2009
• Completion date: August 2011