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Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer

NCT00368329 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2012-07-16

No results posted yet for this study

Summary

To study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating the acute and late toxicity of treatment.

Conditions

  • Esophageal Neoplasms
  • Carcinoma, Squamous Cell
  • Adenocarcinoma
  • Esophageal Cancer

Interventions

DRUG

Capecitabine (Xeloda)

PO bid daily on RT days: 500mg \& 150mg tabs for dose 825mg/m2 bid AM/PM (total daily dose 1650mg/m2)

DRUG

[18-F] Fluorodeoxyglucose (FDG)

5-10 mCi IV administration

DRUG

5-Fluorouracil (5-FU)

200mg/m2 continuous venous infusion

DRUG

Carboplatin

AUC 2, based onCalvert formula IV infusion

Sponsors & Collaborators

Principal Investigators

  • Daniel T Chang · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT00368329 on ClinicalTrials.gov