Know Cancer

or
forgot password

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


Phase 3
21 Years
N/A
Not Enrolling
Female
Sarcoma

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Aaron H. Wolfson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000063303

NCT ID:

NCT00002546

Start Date:

December 1993

Completion Date:

Related Keywords:

  • Sarcoma
  • stage I uterine sarcoma
  • stage II uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • uterine carcinosarcoma
  • Carcinosarcoma
  • Uterine Neoplasms
  • Sarcoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Women's Cancer Center - Los GatosLos Gatos, California  95032
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
Rush University Medical CenterChicago, Illinois  60612-3824
CCOP - EvanstonEvanston, Illinois  60201
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Cancer Center at Tufts - New England Medical CenterBoston, Massachusetts  02111
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University HospitalCamden, New Jersey  08103-1489
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Gynecologic Oncology NetworkGreenville, North Carolina  27858
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Fletcher Allen Health Care - Medical Center Hospital of Vermont CampusBurlington, Vermont  05401
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405