Status:
COMPLETED
Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus
Lead Sponsor:
Montefiore Medical Center
Conditions:
Uterine Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The optimal sequence and /or modality for adjuvant therapy in the management of Mixed Mesodermal Tumors (MMT) clearly remains to be established. The rationale for the protocol is to "sandwich" pelvic ...
Detailed Description
Uterine sarcomas account for only 2-4% of uterine malignancies, yet they are responsible for 26% of uterine cancer deaths. Mixed mesodermal tumors (MMT), previously known as carcinosarcoma, are the mo...
Eligibility Criteria
Inclusion
- Histologically documented mixed mesodermal tumor (MMT) of uterus with no visible residual disease.
- Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node sampling.
- Surgical staging should be completed 6 weeks ± 7 days prior to enrollment.
- Age \>= 18 years.
- Written voluntary informed consent.
Exclusion
- Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:
- Total serum bilirubin \>1.5mg/dl
- History of chronic or active hepatitis
- Serum creatinine \>2.0 mg/dl
- Platelets \<100,000/mm3
- Absolute neutrophil count (ANC) \<1500/mm3
- Hemoglobin \<8.0 g/dl (the patient may be transfused prior to study entry)
- Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.
- Patients with any prior chemotherapy or radiotherapy for pelvic malignancy.
- Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry.
- Patient has a uterine sarcoma other then mixed mesodermal tumor (MMT).
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00231842
Start Date
February 1 2003
End Date
July 1 2011
Last Update
January 23 2019
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10461