Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002546

Collaborator

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

216

Enrollment

Locations

3.3

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: cisplatin Drug: ifosfamide Procedure: adjuvant therapy Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES:

Compare the survival, progression-free interval, and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin.
Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks, followed by radiotherapy boost to the pelvis 5 days a week for 2.2 weeks.
Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4. Treatment continues every 3 weeks for 3 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Phase III Randomized Study of Accelerated Hyperfractionated Whole Abdominal Radiotherapy (AHWAR) Versus Combination Ifosfamide-Mesna With Cisplatin in Optimally Debulked Stage I, II, III, or IV Carcinosarcoma (CS) of The Uterus

Study Start Date :

Dec 1, 1993

Actual Primary Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed primary homologous or heterologous carcinosarcoma of the uterus (corpus and cervix)
Surgical stage I-IV disease, including positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, involvement of the mucosa of the bowel, bladder, or rectum, intra-abdominal metastases, positive pelvic washings, or vaginal involvement within planned radiation port
Prior total abdominal hysterectomy with bilateral salpingo-oophorectomy and maximum tumor resection of all gross intra-abdominal/pelvic disease, including grossly involved pelvic and para-aortic nodes within 8 weeks before study
No greater than 1 cm residual disease
Cervical sarcomas also allowed
No metastasis beyond the abdominal cavity at diagnosis, including the following:
Parenchymal liver metastasis
Lung metastasis
Positive inguinal lymph nodes
Positive scalene nodes
Radiographic or pathologic evidence of bone or brain metastasis

PATIENT CHARACTERISTICS:

Age:

21 and over

Performance status:

GOG 0-2

Hematopoietic:

WBC at least 3,000/mm3
Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal
Albumin at least 3 g/dL
No acute hepatitis

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 50 mL/min

Other:

No septicemia
No severe infection
No severe gastrointestinal bleeding
No prior invasive or concurrent malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Prior hormonal therapy allowed

Radiotherapy:

See Disease Characteristics
No prior radiotherapy

Surgery:

See Disease Characteristics

Other:

No prior therapy that would preclude study therapy

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	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
3	Women's Cancer Center - Los Gatos	Los Gatos	California	United States	95032
4	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California	United States	92868
5	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado	United States	80010
6	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
7	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
8	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
9	Rush University Medical Center	Chicago	Illinois	United States	60612-3824
10	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612
11	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
12	CCOP - Central Illinois	Decatur	Illinois	United States	62794-9640
13	CCOP - Evanston	Evanston	Illinois	United States	60201
14		Hinsdale	Illinois	United States	60521
15	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
16	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
17	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
18	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
19	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
20	Cancer Center at Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
21	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts	United States	01605-2982
22	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
23	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
24	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
25	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
26	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
27	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
28	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
29	Keesler Medical Center - Keesler Air Force Base	Keesler AFB	Mississippi	United States	39534-2576
30	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
31	CCOP - Kansas City	Kansas City	Missouri	United States	64131
32	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
33	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
34	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
35	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
36	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
37	Cancer Institute of New Jersey at the Cooper University Hospital	Camden	New Jersey	United States	08103-1489
38	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
39	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
40	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York	United States	11790-7775
41	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7570
42	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
43	Gynecologic Oncology Network	Greenville	North Carolina	United States	27858
44	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1065
45	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267-0526
46	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44106
47	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio	United States	43210-1240
48	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73104
49	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
50	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001-3788
51	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
52	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
53	Abramson Cancer Center at the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
54	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107
55	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111-2497
56	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania	United States	15213-3180
57	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee	United States	37917
58	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee	United States	37232-2516
59	University of Texas Medical Branch	Galveston	Texas	United States	77555-0587
60	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
61	Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus	Burlington	Vermont	United States	05401
62	Cancer Center at the University of Virginia	Charlottesville	Virginia	United States	22908
63	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024
64	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
65	Pretoria Academic Hospital	Pretoria		South Africa	0001

Sponsors and Collaborators

Gynecologic Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group

Investigators

Study Chair: Aaron H. Wolfson, MD, University of Miami Sylvester Comprehensive Cancer Center
Study Chair: Higinia R. Cardenes, MD, PhD, Indiana University Melvin and Bren Simon Cancer Center