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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00002976

Collaborator

National Cancer Institute (NCI) (NIH), Eastern Cooperative Oncology Group (Other), Southwest Oncology Group (Other)

2,108

Enrollment

149

Locations

14.1

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: conjugated estrogens	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2108 participants

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

Study Start Date :

Jun 1, 1997

Actual Primary Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
3	CCOP - Greater Phoenix	Phoenix	Arizona	United States	85006-2726
4	Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)	Phoenix	Arizona	United States	85012
5	Veterans Affairs Medical Center - Tucson	Tucson	Arizona	United States	85723
6	Arizona Cancer Center	Tucson	Arizona	United States	85724
7	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
8	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas	United States	72205
9	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
10	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
11	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California	United States	90073
12	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
13	Community Hospital of Los Gatos	Los Gatos	California	United States	95032
14	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
15	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
16	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
17	University of California Davis Medical Center	Sacramento	California	United States	95817
18	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California	United States	95403
19	David Grant Medical Center	Travis Air Force Base	California	United States	94535
20	University of Colorado Cancer Center	Denver	Colorado	United States	80010
21	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
22		New Britain	Connecticut	United States	06052
23	MBCCOP-Howard University Cancer Center	Washington	District of Columbia	United States	20060
24	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
25	Mayo Clinic	Jacksonville	Florida	United States	32224
26	Sacred Heart Hospital of Pensacola	Pensacola	Florida	United States	32504
27	Tampa Bay Cancer Consortium	Saint Petersburg	Florida	United States	33701
28	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
29	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342-1701
30	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia	United States	30905-5650
31	Medical College of Georgia Comprehensive Cancer Center	Savannah	Georgia	United States	31403-3089
32	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813-2424
33	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859-5000
34	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611-3013
35	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
36	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
37	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
38	CCOP - Central Illinois	Decatur	Illinois	United States	62526
39	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois	United States	60141
40	Loyola University Medical Center	Maywood	Illinois	United States	60153
41	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
42	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
43	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
44	Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242-1009
45	University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7390
46	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
47	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
48	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky	United States	40502-2236
49	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
50	Earl K. Long Medical Center	Baton Rouge	Louisiana	United States	70805
51	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
52	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
53	Ochsner Clinic	New Orleans	Louisiana	United States	70121
54	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana	United States	71130-3932
55	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71130
56	Boston Medical Center	Boston	Massachusetts	United States	02118
57	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts	United States	02130
58	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan	United States	48105
59	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
60	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0912
61	Veterans Affairs Medical Center - Detroit	Detroit	Michigan	United States	48201-1932
62	Henry Ford Hospital	Detroit	Michigan	United States	48202
63	Butterworth Hospital	Grand Rapids	Michigan	United States	49503
64	CCOP - Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan	United States	49503
65	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
66	CCOP - Beaumont	Royal Oak	Michigan	United States	48073-6769
67	Providence Hospital - Southfield	Southfield	Michigan	United States	48075-9975
68	CCOP - Duluth	Duluth	Minnesota	United States	55805
69	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
70	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi	United States	39531-2410
71	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
72	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi	United States	39216
73	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi	United States	39534-2576
74	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
75	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
76	CCOP - Kansas City	Kansas City	Missouri	United States	64131
77	St. Louis University Health Sciences Center	Saint Louis	Missouri	United States	63110
78	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
79	Department of OB-GYN	Saint Louis	Missouri	United States	63117
80	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
81	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
82	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
83	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
84	Methodist Cancer Center - Omaha	Omaha	Nebraska	United States	68114
85	Cooper Hospital/University Medical Center	Camden	New Jersey	United States	08103-1489
86	Morristown Memorial Hospital	Morristown	New Jersey	United States	07962-1956
87	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico	United States	87108-5138
88	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
89	Cancer Center of Albany Medical Center	Albany	New York	United States	12208
90	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
91	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
92	Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
93	University of Rochester Medical Center	Rochester	New York	United States	14642
94	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York	United States	11794-8091
95	Crouse Hospital	Syracuse	New York	United States	13210
96	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
97	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
98	Southern Pines Women's Health Center	Southern Pines	North Carolina	United States	28388-0749
99	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
100	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1065
101	University of Tennessee Cancer Institute	Winston-Salem	North Carolina	United States	27157-1065
102	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio	United States	45220-2288
103	Barrett Cancer Center	Cincinnati	Ohio	United States	45267-0501
104	Ireland Cancer Center	Cleveland	Ohio	United States	44106
105	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195-9001
106	CCOP - Columbus	Columbus	Ohio	United States	43206
107	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
108	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
109	CCOP - Dayton	Kettering	Ohio	United States	45429
110	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
111	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma	United States	73104
112	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
113	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97207
114	Good Samaritan Hospital Comprehensive Cancer Center	Portland	Oregon	United States	97210
115	CCOP - Columbia River Program	Portland	Oregon	United States	97225
116	OHSU Cancer Institute	Portland	Oregon	United States	97239
117	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001-3788
118	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
119	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
120	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina	United States	29401-5799
121	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
122	CCOP - Greenville	Greenville	South Carolina	United States	29615
123	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
124	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104
125	Baptist Regional Cancer Center - Knoxville	Knoxville	Tennessee	United States	37901
126	University of Tennessee Medical Center at Knoxville	Knoxville	Tennessee	United States	37920
127	Brookview Research, Inc.	Nashville	Tennessee	United States	37203
128	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
129	University of Texas Medical Branch	Galveston	Texas	United States	77555-0587
130	CCOP - M.D. Anderson Research Base	Houston	Texas	United States	77030-4009
131	Covenant Health System	Lubbock	Texas	United States	79410
132	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7845
133	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78284
134	Veterans Affairs Medical Center - Temple	Temple	Texas	United States	76504
135	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
136	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112-5550
137	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah	United States	84148
138	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont	United States	05401
139	Cancer Center at the University of Virginia	Charlottesville	Virginia	United States	22908
140	Eastern Virginia Medical School	Norfolk	Virginia	United States	23510-1115
141	Massey Cancer Center	Richmond	Virginia	United States	23298-0037
142	University of Virginia at Roanoke	Roanoke	Virginia	United States	24013
143	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
144	Swedish Cancer Institute	Seattle	Washington	United States	98104
145	Veterans Affairs Medical Center - Seattle	Seattle	Washington	United States	98108
146	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024
147	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
148	Madigan Army Medical Center	Tacoma	Washington	United States	98431-5000
149	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54301