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Phase III Randomized Study of Whole Abdominal Radiotherapy Versus Ifosfamide and Cisplatin in Patients With Optimally Debulked Stage I-IV Carcinosarcoma of the Uterus
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 | Protocol IDs |
---|
Phase III | Treatment | Completed | 21 and over | GOG-0150 ECOG-G150, NCT00002546 |
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.
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: 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: Performance status: 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 216A 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. Published ResultsWolfson 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 ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | Aaron Wolfson, MD, Protocol chair | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) |
Eastern Cooperative Oncology Group ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | Higinia Cardenes, MD, PhD, Protocol chair | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) |
Registry Information | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | 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 | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 1993-12-27 | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2009-01-25 | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00002546 | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 1993-12-27 | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2005-11-02 | ![](https://webarchive.library.unt.edu/web/20090514230848im_/http://www.cancer.gov/images/spacer.gif) | NCI Grant/Contract Number | | U10-CA27469 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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