Phase 2
Completed N=30
Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus
Uterine Cancer
Source: ClinicalTrials.gov NCT00231842 ↗
Enrolled (actual)
30
Serious AEs
48.2%
Results posted
Jan 2019
Primary outcomePrimary: Cycles With Hematologic Toxicities — 11; 14; 6; 0 Cycles
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cycles With Hematologic Toxicities |
11; 14; 6; 0; 6; 2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT00231842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.