NCT00999700

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The objective of this trial is to determine whether Cetuximab and radiation preceded by an induction chemotherapy, may be superior to an established chemoradiation program for HNC (RTOG regimen, Adelstein DJ J.Clin.Oncol. 2003;21:92-98).

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2016-12-31
• Completion: 2021-12-01
• First posted: 2009-10-22
• Last updated: 2017-09-05

Locations

21 sites across 1 country: Italy