CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Cisplatin +6 moredrug
Likely dose
Cisplatin and Irinotecan given IV (specific doses not stated in available text)AI-extracted
Key inclusion· 6
  • Histologically confirmed adenocarcinoma of stomach or gastroesophageal junction with bulk of disease in stomach
  • Locally advanced disease meeting specific staging: Tany N+ M0 or T3-T4 Nany M0 (excluding T1-2N0M0)
  • Disease must be potentially curable by surgery without evidence of distant metastases
  • Karnofsky Performance Status ≥60% (ECOG ≤2)
Key exclusion· 6
  • Any metastatic disease (M1)
  • NYHA Class III or IV heart disease; history of myocardial infarction or active angina within 6 months
  • Grade 2 or greater pre-existing peripheral neuropathy
  • Clinically significant auditory impairment or hearing loss

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

Search/NCT00062374
NCT00062374Phase 2Completed

An Evaluation of Preoperative Chemotherapy With Irinotecan and Cisplatin for Advanced, But Resectable Gastric Cancer: A Coordinated Multidisciplinary, Multicenter Study Linking Functional Imaging, Genomic Expression Profiles and Histopathology

National Cancer Institute (NCI)·interventional·Posted Jun 6, 2003·Updated Jul 6, 2017

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Computed Tomography, and 5 other interventions for Gastric Adenocarcinoma and 3 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2003
Enrollment StartJun 1, 2003
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 23.1 years ago

Interventions

Cisplatindrug

Given IV

Computed Tomographyprocedure

Undergo FDG and FLT PET/CT

Fludeoxyglucose F-18radiation

Undergo FDG-PET/CT

Fluorothymidine F-18other

Undergo FLT-PET/CT

Irinotecan Hydrochloridedrug

Given IV

Positron Emission Tomographyprocedure

Undergo FDG and FLT PET/CT

Therapeutic Conventional Surgeryprocedure

Undergo radical subtotal or total gastrectomy with lymph node dissection