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NCT00231868 · ClinicalTrials.gov registry record · Phase 2
A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma
A Phase 2 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT00231868 is a Phase 2 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 81 participants.
The verdict
NCT00231868, a Phase 2 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution with the sequential use of radiation "sandwiched" between paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy, two of which required a 1 week treatment delay. There were no cases of grade 3 or 4 thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median follow up of 15 months, we have not observed late toxicities. Given these favorable preliminary findings, supported by recently published data documenting efficacy of the "sandwich" multimodality technique in other difficult uterine malignancies (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible benefits in progression-free and overall survival.
Interventions
- DRUG Carboplatin and Paclitaxel and Pelvic Radiation Therapy
- PROCEDURE Carboplatin and Paclitaxel and Pelvic Radiation Therapy
- DRUG Carboplatin and Paclitaxel and Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2001-12 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00231868
The ClinicalTrials.gov registry entry for NCT00231868 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Carboplatin and Paclitaxel and Pelvic Radiation Therapy is the first listed.
NCT00231868 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00231868 about?
NCT00231868 is a clinical study titled "A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma". Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution wi...
What is the current status of trial NCT00231868?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2001-12. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00231868?
The interventions under investigation include: Carboplatin and Paclitaxel and Pelvic Radiation Therapy (DRUG), Carboplatin and Paclitaxel and Pelvic Radiation Therapy (PROCEDURE), Carboplatin and Paclitaxel and Radiation Therapy (DRUG).
Who is sponsoring clinical trial NCT00231868?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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