CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Cisplatin +2 moredrug
Likely dose
Cisplatin 30mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00590031
NCT00590031Phase 2Completed
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Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 10, 2008·Updated Jan 25, 2016

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Irinotecan, and 1 other intervention for Esophageal Carcinoma. Completed, enrolled 61 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2008
Enrollment StartNov 1, 2002
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 18.5 years ago

Interventions

Cisplatindrug

pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12

Irinotecandrug

Irinotecan will be given 65 mg/m2

External Beam Radiation Therapyradiation

will be delivered with multiple (\>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.