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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

Phase 3
21 Years
Not Enrolling

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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


- 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


- 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



- 21 and over

Performance status:

- GOG 0-2


- WBC at least 3,000/mm3

- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Albumin at least 3 g/dL

- No acute hepatitis


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min


- No septicemia

- No severe infection

- No severe gastrointestinal bleeding

- No prior invasive or concurrent malignancy within the past 5 years except nonmelanoma
skin cancer


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Prior hormonal therapy allowed


- See Disease Characteristics

- No prior radiotherapy


- See Disease Characteristics


- No prior therapy that would preclude study therapy

Type of Study:


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


United States: Federal Government

Study ID:




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



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