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Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)

NCT00117572 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2018-04-09

Study results available
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Summary

The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

Conditions

  • Cancer of the Pharynx
  • Cancer of the Larynx
  • Cancer of the Nasal Cavity
  • Paranasal Sinus Neoplasms
  • Cancer of the Oral Cavity

Interventions

DRUG

docetaxel

75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)

DRUG

cisplatin

75 mg/m2 on day 1

DRUG

hydroxyurea

Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)

DRUG

fluorouracil

750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)

PROCEDURE

chemotherapy

See protocol for details

PROCEDURE

radiotherapy

See protocol for details

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Everett Vokes, M.D. · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States
  • Croatia
  • France
  • Russia
  • Spain

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 NCT00117572 on ClinicalTrials.gov