CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Docetaxel +4 moredrug
Likely dose
Docetaxel 20 mg/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/NCT01217060
NCT01217060Phase 2Completed
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Phase IIB Study of Trimodality Management of Clinical T1bN0M0 Cancers of the Esophagus

M.D. Anderson Cancer Center·interventional·Posted Oct 8, 2010·Updated Apr 13, 2021

In Brief

A Phase 2 clinical trial evaluating Docetaxel, 5-FU, and 3 other interventions for Esophageal Cancer. Completed, enrolled 4 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if giving chemotherapy and radiation therapy before surgery for early-stage esophageal cancer can help to control the disease and if so, for how long. The safety of this treatment will also be studied.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2010
Enrollment StartOct 1, 2010
Primary CompletionJun 14, 2020
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 15.7 years ago

Interventions

Docetaxeldrug

20 mg/m2 given by vein (IV) over 1 hour once a week for up to 5 1/2 weeks.

5-FUdrug

300 mg/m2 given by vein, continuously for 96 hours a week for about 5 1/2 weeks.

Radiotherapyradiation

50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks, Monday through Friday.

Esophagectomyprocedure

Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.

Dexamethasonedrug

10 mg IV 30 minutes prior to weekly Docetaxel.