Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.

Conditions

• Breast Cancer

Interventions

RADIATION

Standard Breast Irradiation

Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.

RADIATION

Breast Radiation plus Regional Radiation

Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NSABP Foundation Inc

  collaborator NETWORK

• Radiation Therapy Oncology Group

  collaborator NETWORK

• SWOG Cancer Research Network

  collaborator NETWORK

• Trans Tasman Radiation Oncology Group

  collaborator OTHER

• North Central Cancer Treatment Group

  collaborator NETWORK

• NCIC Clinical Trials Group

  lead NETWORK

Principal Investigators

• Timothy J. Whelan, MD · Margaret and Charles Juravinski Cancer Centre

• David S. Parda · Allegheny Cancer Center at Allegheny General Hospital

• Julia R. White, MD · Medical College of Wisconsin

• Lori J. Pierce, MD · University of Michigan Rogel Cancer Center

• Boon Chua, MD · Peter MacCallum Cancer Centre, Australia

• Laura A. Vallow, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

120 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-03-09

Primary Completion

2014-11-20

Completion

2017-04-19

Countries

• Canada

Study Locations