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Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin

NCT00999700 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2017-09-05

No results posted yet for this study

Summary

A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

docetaxel - cisplatin - 5-fluorouracil

docetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21

RADIATION

radiotherapy

Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.

DRUG

cetuximab

400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment

DRUG

cisplatin

Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.

RADIATION

radiotherapy

Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.

Sponsors & Collaborators

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Principal Investigators

  • MARCO MERLANO, MD · ASCO, ESMO, AIOM, G.O.N.O.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2016-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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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 NCT00999700 on ClinicalTrials.gov