Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer

Sponsor

Radiation Therapy Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00006027

Collaborator

National Cancer Institute (NCI) (NIH), Gynecologic Oncology Group (Other)

Locations

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: cisplatin Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy	Phase 3

Detailed Description

OBJECTIVES:

Compare the relapse-free survival in patients with stage I or II endometrial cancer treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total abdominal hysterectomy and bilateral salpingo-oophorectomy.
Compare the patterns of recurrence and the acute and late toxicity profiles associated with these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.

Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a week for 5.5 weeks.
Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 2-4 hours on days 56, 84, 112, and 140.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this study.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer

Study Start Date :

Aug 1, 2000

Actual Primary Completion Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed uterine confined endometrioid endometrial adenocarcinoma with one of the following:
Grade 2 or 3 carcinoma with more than 50% myometrial invasion (stage IC and IIA)
Grade 2 or 3 carcinoma with stromal invasion of the cervix (stage IIB)
No grade I adenocarcinoma
Less than 50% papillary serous or clear cell histology on pathologic specimen
Prior hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy with or without additional surgical staging for endometrial cancer no more than 8 weeks prior to study
No known metastatic extrauterine metastases, known gross residual disease, positive peritoneal cytology, or distant metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,800/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic:

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

Renal:

Creatinine no greater than 1.5 mg/dL

Cardiovascular:

No cardiac dysrhythmias

Other:

No other malignancy within the past 5 years except nonmelanomatous skin cancer
No medical contraindications to study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy

Surgery:

See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1740
2	Community Hospital of Los Gatos	Los Gatos	California	United States	95032
3	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California	United States	92868
4	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado	United States	80010
5	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
6	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
7	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1009
8	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
9	Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
10	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
11	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
12	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
13	Cooper University Hospital	Camden	New Jersey	United States	08103-1489
14	State University of New York Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
15	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
16	Long Island Cancer Center at Stony Brook University Hospital	Stony Brook	New York	United States	11794-8091
17	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
18	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
19	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1065
20	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma	United States	73190
21	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
22	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
23	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425-2233
24	Brookview Research, Inc.	Nashville	Tennessee	United States	37203
25	University of Texas Medical Branch	Galveston	Texas	United States	77555-0587
26	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024
27	Tacoma General Hospital	Tacoma	Washington	United States	98405
28	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin	United States	54449
29	Norwegian Radium Hospital	Oslo		Norway	N-0310