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Trimodality Management of T1b Esophageal Cancers

NCT01217060 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-04-13

Study results available
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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.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Docetaxel

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

DRUG

5-FU

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

RADIATION

Radiotherapy

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

PROCEDURE

Esophagectomy

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

DRUG

Dexamethasone

10 mg IV 30 minutes prior to weekly Docetaxel.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Steven H. Lin, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2020-06-14
Completion
2020-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217060 on ClinicalTrials.gov