CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
capecitabine +5 moredrug
Likely dose
Not stated in 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/NCT00938470
NCT00938470Phase 2Completed

Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia

Alliance for Clinical Trials in Oncology·interventional·Posted Jul 13, 2009·Updated Mar 29, 2018

In Brief

A Phase 2 clinical trial evaluating capecitabine, docetaxel, and 4 other interventions for Adenocarcinoma of the Gastroesophageal Junction and 2 related conditions. Completed, enrolled 73 participants across 187 sites.

Detailed Summary

This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine, fluorouracil, and radiation therapy works compared with fluorouracil when given together with oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2009
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.0 years ago

Interventions

capecitabinedrug

Given PO

docetaxeldrug

Given IV

fluorouracildrug

Given IV

oxaliplatindrug

Given IV

radiation therapyradiation

Undergo radiation therapy

therapeutic conventional surgeryprocedure

Undergo surgery