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Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer

NCT00573131 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2022-06-22

Study results available
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Summary

OncoGel is a new experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.

The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and 5-FU) and radiation therapy before surgery.

Conditions

Interventions

DRUG

OncoGel (Paclitaxel gel)

6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy

DRUG

cisplatin

75 mg/m2 IV (in the vein) once on Day 1 and Day 29

DRUG

5-FU

1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29

RADIATION

radiation therapy

50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks

PROCEDURE

esophageal resection

Removal of esophagus after completion of chemotherapy and radiation therapy

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Kirk D Fowers, PhD · Boston Scientific Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Czechia
  • India
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00573131 on ClinicalTrials.gov