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Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer

This study has been terminated.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00002976
First received: November 1, 1999
Last updated: April 10, 2013
Last verified: April 2003
History of Changes
  Purpose

RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect cancer recurrence.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen replacement therapy in treating women who have stage I or stage II endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
 Drug: conjugated estrogens
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 2108
Study Start Date: June 1997
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the effect of estrogen replacement therapy on recurrence free and overall survival in women with a history of stage I or II endometrial adenocarcinoma.

OUTLINE: This is a randomized, double blind study. Patients are stratified according to stage of endometrial cancer (IA vs IB/IC vs II). Patients are randomized to one of two treatment arms:

  • Arm I: Patients receive oral conjugated estrogens (Premarin) daily for 3 years.
  • Arm II: Patients receive oral placebo daily for 3 years. Patients are followed every 6 months for 3 years and then annually for 2 years.

PROJECTED ACCRUAL: Approximately 2,108 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed grade I, II or III endometrial adenocarcinoma (endometrioid, villoglandular, mucinous, adenosquamous, papillary serous, clear cell, or not otherwise specified)

  • Must have had total hysterectomy and bilateral salpingo-oophorectomy within past 20 weeks

    • Surgical stage IA, IB, IC, IIA (occult), or IIB (occult) disease
  • Must have had normal mammogram, or a negative breast biopsy after an abnormal mammogram, within past year

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • No acute liver disease

Renal:

  • Not specified

Cardiovascular:

  • No prior thromboembolic disease

Other:

  • No prior or current carcinoma of the breast
  • No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent hormonal therapy

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • No prior cancer treatment that would preclude study therapy
  • Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002976

  Show 149 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
Investigators
Study Chair: Richard R. Barakat, MD Memorial Sloan-Kettering Cancer Center
Study Chair: Scott Wadler, MD Albert Einstein College of Medicine of Yeshiva University
Study Chair: David S. Alberts, MD University of Arizona
  More Information

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

Publications:

ClinicalTrials.gov Identifier: NCT00002976     History of Changes
Other Study ID Numbers: CDR0000065498, GOG-137A, E-G0137, SWOG-G0137
Study First Received: November 1, 1999
Last Updated: April 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013