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Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer
This study has been terminated.
Sponsor:
Gynecologic Oncology Group
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
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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:
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) |
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002976
Show 149 Study 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, Inc. |
| Study Chair: | David S. Alberts, MD | University of Arizona |
More Information
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 |
Keywords provided by Gynecologic Oncology Group:
|
stage I endometrial carcinoma stage II endometrial carcinoma endometrial adenocarcinoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases |
Genital Diseases, Female Estrogens, Conjugated (USP) Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 27, 2017