Clinical trial · Interventional
Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus
A Pilot Phase II Trial of Adjuvant Radiation Therapy "Sandwiched" Between Ifosfamide in Patients With Mixed Mesodermal Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Radiation Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ifosfamide with or without cisplatin
- description
- Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin with cisplatin (20 mg/m2/day for 5 days) evrey 3 weeks. cisplatin added toxicity without additional efficacy, so mid-study, cisplatin was eliminated.
- interventionNames
- Drug: Ifosfamide
- Device: Radiation Therapy
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Cycles With Hematologic Toxicities
- timeFrame
- 2 years
- description
- Out of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTEinstein MH, Klobocista M, Hou JY, Lee S, Mutyala S, Mehta K, Reimers LL, Kuo DY, Huang GS, Goldberg GL. Phase II trial of adjuvant pelvic radiation "sandwiched" between ifosfamide or ifosfamide plus cisplatin in women with uterine carcinosarcoma. Gynecol Oncol. 2012 Jan;124(1):26-30. doi: 10.1016/j.ygyno.2011.10.008. Epub 2011 Nov 3. PMID 22055846