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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002546 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: cisplatin Drug: ifosfamide Procedure: adjuvant therapy Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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 |
| Estimated Enrollment: | 216 |
| Study Start Date: | December 1993 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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 metastasis beyond the abdominal cavity at diagnosis, including the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 65 Study Locations| Study Chair: | Aaron H. Wolfson, MD | University of Miami Sylvester Comprehensive Cancer Center - Miami |
| Study Chair: | Higinia R. Cardenes, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| Study ID Numbers: | CDR0000063303, GOG-0150, ECOG-G150 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002546 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I uterine sarcoma stage II uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma uterine carcinosarcoma |
|
Adjuvants, Immunologic Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Genital Diseases, Female Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas Ifosfamide Radiation-Sensitizing Agents |
Cisplatin Mechlorethamine Uterine Sarcoma Sarcoma Uterine Neoplasms Antineoplastic Agents, Alkylating Alkylating Agents Mesna Carcinosarcoma Isophosphamide mustard |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Pharmacologic Actions Genital Diseases, Female Neoplasms, Connective and Soft Tissue Neoplasms |
Ifosfamide Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Sarcoma Uterine Neoplasms Antineoplastic Agents, Alkylating Alkylating Agents Isophosphamide mustard |