Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	21 and over	NCI	GOG-0150 ECOG-G150, NCT00002546

Objectives

1. 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.
2. Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population.

Entry 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

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

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

Expected Enrollment

A total of 216 patients will be accrued for this study within 6 years.

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.

Wolfson AH, Brady MF, Rocereto T, et al.: A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol 107 (2): 177-85, 2007.[PUBMED Abstract]

Wolfson AH, Brady MF, Mannel RS, et al.: A Gynecologic Oncology Group randomized trial of whole abdominal irradiation (WAI) vs cisplatin-ifosfamide+mesna (CIM) in optimally debulked stage I-IV carcinosarcoma (CS) of the uterus. [Abstract] J Clin Oncol 24 (Suppl 18): A-5001, 256s, 2006.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Aaron Wolfson, MD, Protocol chair		Ph: 305-243-4210 Email: awolfson@med.miami.edu

Eastern Cooperative Oncology Group

Higinia Cardenes, MD, PhD, Protocol chair		Ph: 317-274-2524; 888-600-4822 Email: hcardene@iupui.edu

Registry Information
Official Title		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
Trial Start Date		1993-12-27
Trial Completion Date		2009-01-25
Registered in ClinicalTrials.gov		NCT00002546
Date Submitted to PDQ		1993-12-27
Information Last Verified		2005-11-02
NCI Grant/Contract Number		U10-CA27469