CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
capecitabine +10 moredrug
Likely dose
Capecitabine (oral) and oxaliplatin (IV) with concurrent radiotherapyAI-extracted
Key inclusion· 6
  • Squamous cell carcinoma or adenocarcinoma of the esophagus
  • Stage II-IVA disease by clinical staging (endoscopy, CT ± EUS)
  • For GEJ tumors, bulk must be in the esophagus
  • ECOG performance status 0-1
Key exclusion· 8
  • Known brain metastases
  • Prior therapy for esophageal cancer
  • Peripheral neuropathy grade ≥2
  • Hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics

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

Search/NCT00470184
NCT00470184Phase 2Completed

Phase II Study of Capecitabine in Combination With Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer

Roswell Park Cancer Institute·interventional·Posted May 7, 2007·Updated Nov 25, 2013

In Brief

A Phase 2 clinical trial evaluating capecitabine, oxaliplatin, and 9 other interventions for Esophageal Cancer. Completed, enrolled 41 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2007
Enrollment StartNov 1, 2006
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 19.2 years ago

Interventions

capecitabinedrug

Oral

oxaliplatindrug

IV

gene expression analysisgenetic

Correlative Study

microarray analysisgenetic

Correlative Study

reverse transcriptase-polymerase chain reactiongenetic

Correlative Study

adjuvant therapyprocedure

Metastatic growth control

biopsyprocedure

Examination of tissue type

conventional surgeryprocedure

Tissue removal

neoadjuvant therapyprocedure

Tumor shrinkage

quality-of-life assessmentprocedure

Correlative Study

radiation therapyradiation

Undergoing radiation therapy