Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus

Completed · Phase 2

Conditions studied: Uterine Cancer

In brief

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 radiation with chemotherapy to decrease distant metastasis. The proposed study will sandwich radiation between the two most active chemotherapeutic agents for MMT identified to date (ifosfamide/cisplatin). By doing so, we attempt to decrease both local and distant recurrence, which may translate into an improved progression free interval and possibly even extend survival.

Key facts

Study ID

NCT00231842

Run by

Montefiore Medical Center

People needed

30

Starts

2003-02-01

Expected to finish

2011-07-01

Last updated by the study team

2019-01-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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