Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B NCIC Clinical Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003857

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.

Condition	Intervention	Phase
Breast Cancer	Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Local recurrence (e.g., invasive or noninvasive recurrence) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Time to distant metastasis [ Designated as safety issue: No ]
Invasive local recurrence [ Designated as safety issue: No ]
Salvage mastectomy rate [ Designated as safety issue: No ]

Estimated Enrollment:	1790
Study Start Date:	December 1999
Estimated Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	26 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003857

Show 369 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

NCIC Clinical Trials Group

Investigators

Study Chair:	Beryl McCormick, MD	Memorial Sloan-Kettering Cancer Center
Investigator:	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
Investigator:	Eileen Rakovitch, MD	Edmond Odette Cancer Centre at Sunnybrook

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067020, RTOG-9804, CAN-NCIC-MA26, CALGB-49801, RTOG-DEV-1026
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003857 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer in situ
ductal breast carcinoma in situ

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Antineoplastic Agents, Hormonal
Skin Diseases
Hormone Antagonists
Citric Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Adjuvants, Immunologic
Breast Neoplasms
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Hormones

Tamoxifen
Carcinoma
Carcinoma, Ductal
Estrogen Receptor Modulators
Carcinoma in Situ
Citrate
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Estrogen Antagonists
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tamoxifen

Pharmacologic Actions
Carcinoma
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009