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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - 120
Updated:4/21/2016
Start Date:December 1993

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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

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.

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.

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
We found this trial at
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1730 E Republic Rd
Springfield, Missouri 65804
(417) 269-4520
CCOP - Cancer Research for the Ozarks Cancer Research for the Ozarks (CRO), also known...
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115 Business loop 70 w
Columbia, Missouri 65203
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Ellis Fischel Cancer Center at University of Missouri - Columbia At Ellis Fischel Cancer Center,...
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4100 John R
Detroit, Michigan 48201
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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125 Science Dr
Durham, North Carolina 27710
888.275.3853
Duke Comprehensive Cancer Center Leading-edge cancer care and research have been a hallmark of Duke...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Albuquerque, New Mexico 87131
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
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101 Manning Drive
Chapel Hill, North Carolina 27514
(919) 966-0000
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
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Charlottesville, Virginia 22908
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cincinnati, Ohio 45267
513-584-7698
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Danville, Pennsylvania 17822
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Decatur, Illinois 62526
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Evanston, Illinois 60201
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100 Michigan Street, NE, MC012
Grand Rapids, Michigan 49503
(616) 391-1230
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Greenville, North Carolina 27858
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Kansas City, Missouri 64131
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Keesler AFB, Mississippi 39534
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
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Minneapolis, Minnesota 55455
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1211 Medical Center Drive
Nashville, Tennessee 37232
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1275 York Ave
New York, New York 10021
(212) 639-2000
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
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Oklahoma City, Oklahoma 73190
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111 S 11th St,
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Phoenix, Arizona 85006
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South Bend, Indiana 46601
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South Bend, Indiana 46617
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1003 S 5th St
Tacoma, Washington 98405
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Temple, Texas 76508
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
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6900 Georgia Ave NW
Washington, District of Columbia 20307
(202) 782-6849
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Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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Worcester, Massachusetts 01655
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