Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00054067

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

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 which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: cisplatin Procedure: adjuvant therapy Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES:

Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy.
Compare the toxicity of these regimens in these patients.
Compare the health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted.
Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.
Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses.
Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy.
Group 3: Patients receive further treatment at the discretion of the investigator.
Completed hysterectomy: Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.
Group A: Patients receive treatment as in group 1 above without intracavity irradiation.
Group B: Patients receive treatment as in group 2 above without intracavity irradiation.
Group C: Patients receive no further treatment.
Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses.

Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months.

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

PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types:
Squamous cell carcinoma
Adenocarcinoma
Adenosquamous carcinoma
Primary, previously untreated disease
Exophytic cervical lesions greater than 4 cm in diameter OR
Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer
No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations)
No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection)
Eligible for radical hysterectomy and lymph node dissection

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

GOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal

Renal

Creatinine no greater than 2.0 mg/dL
No renal abnormalities requiring modification of radiation fields

Gastrointestinal

No gastrointestinal bleeding
No intestinal obstruction

Other

Not pregnant
Negative pregnancy test
No septicemia or severe infection
No other invasive malignancy with any evidence of disease within the past 5 years except nonmelanoma skin cancer
No circumstances that would preclude study completion or required follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics
No prior hysterectomy (total or subtotal)

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	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1740
4	Women's Cancer Center at Community Hospital of Los Gatos	Los Gatos	California	United States	95032
5	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California	United States	92868
6	Yale Comprehensive Cancer Center	New Haven	Connecticut	United States	06520-8028
7	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
8	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
9	Rush-Presbyterian-St. Luke's 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	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
15	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
16	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
17	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
18	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
19	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
20	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
21	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
22	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
23	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
24	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
25	CCOP - Kansas City	Kansas City	Missouri	United States	64131
26	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
27	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
28	Cooper University Hospital	Camden	New Jersey	United States	08103-1489
29	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
30	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York	United States	11790-7775
31	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
32	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
33	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267-0526
34	Ireland Cancer Center	Cleveland	Ohio	United States	44106
35	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
36	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
37	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001-3788
38	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
39	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
40	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104-4283
41	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107
42	Magee-Womens Hospital	Pittsburgh	Pennsylvania	United States	15213-3180
43	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee	United States	37917
44	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee	United States	37232-2516
45	University of Texas Medical Branch	Galveston	Texas	United States	77555-0587
46	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
47	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
48	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont	United States	05401
49	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6188
50	Kagoshima City Hospital	Kagoshima City		Japan	892-8580