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Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer

NCT00868491 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-18

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.

Conditions

Interventions

DRUG

docetaxel, cisplatin, 5-fluorouracil

docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles

RADIATION

radiotherapy

Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks - weeks 14 - 20 of the study protocol

DRUG

cetuximab, cisplatin

* cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20 * cisplatin 30 mg/m2 I.V. weeks 14-20 (concomitantly with radiothrapy)

Sponsors & Collaborators

  • Institute of Oncology Ljubljana

    lead OTHER

Principal Investigators

  • Primož Strojan, MD · Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-12-31
Completion
2011-10-30

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

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 NCT00868491 on ClinicalTrials.gov