Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003857
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 25, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
NCIC Clinical Trials Group
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy Phase 3

Detailed Description:

OBJECTIVES:

  • Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast.
  • Compare distant disease-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years.
  • Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
Actual Study Start Date : December 1999
Actual Primary Completion Date : February 2004
Actual Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Observation +/- tamoxifen for 5 years
Observation +/- tamoxifen 20 mg per day for 5 years
 Drug: tamoxifen citrate
Procedure: adjuvant therapy
Experimental: Radiation therapy +/- tamoxifen for 5 years
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
 Drug: tamoxifen citrate
Procedure: adjuvant therapy
Radiation: radiation therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Local recurrence (e.g., invasive or noninvasive recurrence) [ Time Frame: From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]
  2. Time to distant metastasis [ Time Frame: From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]
  3. Invasive local recurrence [ Time Frame: From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]
  4. Salvage mastectomy rate [ Time Frame: Analysis occurs after all patients have been potentially followed for 5 years. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   26 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis

    • Unicentric
    • Lesions ≤ 2.5 cm
    • Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in < one third of the involved ducts
    • Inked margins ≥ 3 mm
    • Clinically node negative
    • Non-palpable
  • No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery
  • No bloody nipple discharge
  • No more than 12 weeks since prior final surgery (arm II only)

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 26 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • No active connective tissue disorders (e.g., lupus or scleroderma)
  • No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills)

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003857


Locations
Show Show 369 study locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Cancer and Leukemia Group B
NCIC Clinical Trials Group
NRG Oncology
Investigators
Layout table for investigator information
Study Chair: Beryl McCormick, MD Memorial Sloan Kettering Cancer Center
OverallOfficial: Clifford A. Hudis, MD Memorial Sloan Kettering Cancer Center
Study Chair: Barbara L. Smith, MD, PhD Massachusetts General Hospital
Study Chair: Timothy J. Whelan, MD Margaret and Charles Juravinski Cancer Centre
OverallOfficial: Eileen Rakovitch, MD Toronto Sunnybrook Regional Cancer Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003857    
Other Study ID Numbers: RTOG-9804
CDR0000067020
CAN-NCIC-MA26
CALGB-49801
NCI-2011-02038 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Keywords provided by Radiation Therapy Oncology Group:
breast cancer in situ
ductal breast carcinoma in situ
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents