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NCT00231842 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Montefiore Medical Center.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00231842: Completed Phase 2 study, sponsored by Montefiore Medical Center.

NCT00231842 is a Phase 2 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00231842, a Phase 2 study, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Cisplatin
  • DRUG Ifosfamide
  • DEVICE Radiation Therapy

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2003-02
Est. Completion 2011-07
Phase Phase 2
Montefiore Medical Center

345 total trials

What the finished NCT00231842 record still lists

NCT00231842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.

NCT00231842 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00231842 about?

NCT00231842 is a clinical study titled "Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus". 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 radiat...

What is the current status of trial NCT00231842?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2003-02. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00231842?

The interventions under investigation include: Cisplatin (DRUG), Ifosfamide (DRUG), Radiation Therapy (DEVICE).

Who is sponsoring clinical trial NCT00231842?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00231842's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00231842, the US trial registry maintained by the National Library of Medicine. NCT00231842 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.