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Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

NCT00352118 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-12-28

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.

Conditions

Interventions

BIOLOGICAL

filgrastim

subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.

BIOLOGICAL

pegfilgrastim

If applicable on day 5, repeating every 3 weeks for 2 courses.

DRUG

cisplatin

Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.

DRUG

docetaxel

Intravenous over 1 hour on day 1.

DRUG

fluorouracil

Intravenous continuously on days 1-4.

PROCEDURE

conventional surgery

As appropriate, neck dissection.

RADIATION

radiation therapy

60 Gy 5 days/week x 6 weeks with cisplatin

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Frank G. Ondrey, MD, PhD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

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 NCT00352118 on ClinicalTrials.gov