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Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma

NCT00525915 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2015-02-09

Study results available
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Summary

The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared.

Objectives:

Primary objective:

Compare the Pathologic Complete Response rate and % of patients with \<50% residual cancer in the resected surgical specimen between Arms A and B.

Secondary objectives:

1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B
2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome.
3. Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.

Conditions

Interventions

DRUG

5-Fluorouracil

Arm A = 250 mg/m\^2 IV over 24 hours for 5 days weekly for 5 weeks. Arm B = 2.2 mg/m\^2 IV over 48 hours on days 1 and 15.

DRUG

Oxaliplatin

Arm A: 40 mg/m\^2 IV daily over 2 hours for 5 weeks Arm B: 100 mg/m\^2 IV on Day 1 and 15

RADIATION

Radiation Therapy

Radiation treatment every weekday for 5 weeks.

PROCEDURE

Surgery

Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jaffer Ajani, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT00525915 on ClinicalTrials.gov