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Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery

NCT00268437 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-07-06

Study results available
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Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.

Conditions

  • Esophageal Cancer

Interventions

DRUG

carboplatin

carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

DRUG

Pemetrexed

Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.

PROCEDURE

conventional surgery

PROCEDURE

neoadjuvant therapy

RADIATION

radiation therapy

Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Aminah Jatoi, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-01-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00268437 on ClinicalTrials.gov