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NCT00590031 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
A Phase 2 study of Esophageal Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT00590031: Completed Phase 2 study of Esophageal Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00590031 is a Phase 2 study of Esophageal Carcinoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 61 participants, below the 2,384-participant average among 17 other Esophageal Carcinoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00590031, a Phase 2 study of Esophageal Carcinoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.
Primary Outcome
Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend
Conditions Studied
Interventions
- DRUG Cisplatin
- RADIATION External Beam Radiation Therapy
- DRUG Irinotecan
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2002-11 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00590031 record still lists
NCT00590031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 2,384-participant average among 17 other Esophageal Carcinoma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Esophageal Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT00590031 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00590031 about?
NCT00590031 is a clinical study titled "Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.". Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy give...
What is the current status of trial NCT00590031?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2002-11. Estimated completion is 2009-12.
What conditions does trial NCT00590031 study?
This clinical trial studies the following conditions: Esophageal Carcinoma.
What interventions are being tested in trial NCT00590031?
The interventions under investigation include: Cisplatin (DRUG), External Beam Radiation Therapy (RADIATION), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT00590031?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00590031 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Esophageal Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00590031's enrollment target sits among peer trials
61 10th of 17 higher than 8 of 17 other Esophageal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Carcinoma 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.
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