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Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

NCT00003857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2022-05-25

No results posted yet for this study

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.

Conditions

Interventions

DRUG

tamoxifen citrate

PROCEDURE

adjuvant therapy

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Beryl McCormick, MD · Memorial Sloan Kettering Cancer Center

  • Clifford A. Hudis, MD · Memorial Sloan Kettering Cancer Center

  • Barbara L. Smith, MD, PhD · Massachusetts General Hospital

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

  • Eileen Rakovitch, MD · Toronto Sunnybrook Regional Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
26 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-12-31
Primary Completion
2004-02-29
Completion
2022-05-20

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003857 on ClinicalTrials.gov