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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Estrogens, conjugated
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) |
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 |
| 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
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, see Learn About Clinical Studies.
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 of Yeshiva University |
| 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 |
| 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:
|
Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases |
Genital Diseases, Female Estrogens Estrogens, Conjugated (USP) Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 28, 2016