Clinical Trials /

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

NCT00003857

Description:

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.

Related Conditions:
  • Ductal Carcinoma In Situ
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
  • 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

Clinical Trial IDs

  • ORG STUDY ID: RTOG-98-04
  • SECONDARY ID: CDR0000067020
  • SECONDARY ID: CAN-NCIC-MA26
  • SECONDARY ID: CALGB-49801
  • SECONDARY ID: RTOG-DEV-1026
  • SECONDARY ID: NCI-2011-02038
  • NCT ID: NCT00003857

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
tamoxifen citrateObservation +/- tamoxifen for 5 years

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Observation +/- tamoxifen for 5 yearsActive ComparatorObservation +/- tamoxifen 20 mg per day for 5 years
  • tamoxifen citrate
Radiation therapy +/- tamoxifen for 5 yearsExperimentalRadiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
  • tamoxifen citrate

Eligibility 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
      
Maximum Eligible Age:120 Years
Minimum Eligible Age:26 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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.
Safety Issue:
Description:
Measure: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.
Safety Issue:
Description:
Measure: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.
Safety Issue:
Description:
Measure:Salvage mastectomy rate
Time Frame:Analysis occurs after all patients have been potentially followed for 5 years.
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Radiation Therapy Oncology Group

Trial Keywords

  • breast cancer in situ
  • ductal breast carcinoma in situ

Last Updated

November 14, 2015