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Phase II Trial of Pemetrexed-Based Induction Chemotherapy Followed by Concomitant Chemoradiotherapy in Previously Irradiated Head and Neck Cancer Patients

NCT01172470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-11-29

No results posted yet for this study

Summary

The purpose of this study is to determine 1-year survival of previously irradiated Head and Neck cancer (HNC) patients with loco-regional recurrent disease treated with induction chemotherapy with pemetrexed and gemcitabine followed concomitant pemetrexed, carboplatin and daily radiotherapy.

Conditions

Interventions

DRUG

Gemcitabine

4 doses of induction chemotherapy every 2weeks, IV (in the vein)

DRUG

Pemetrexed

Induction Chemotherapy: 4 doses of induction chemotherapy every 2weeks(Days 1, 15, 28, and 42), through an infusion for approximately 10 minutes. Chemoradiotherapy: Day 1,22, and 43through IV infusion over a period of 10 minutes

DRUG

Carboplatin

Chemoradiotherapy: Day 1, 22 and 4 through IV infusion over a period of 1 hour.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Ezra Cohen, MD · The University of Chicago Medical Center

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
2005-06-30
Primary Completion
2007-06-30
Completion
2010-07-31

Countries

  • United States

Study Locations

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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 NCT01172470 on ClinicalTrials.gov