NCT02383966

Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer

A Multicenter, Randomized, Open-label, Phase III Trial to Assess Efficacy and Safety of Cetuximab When Given in Combination With Cisplatin Plus 5 Fluorouracil Versus Cisplatin Plus 5-fluorouracil Alone for the First-line Treatment of Chinese Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.

Conditions

• Carcinoma, Squamous Cell of Head and Neck

Interventions

Type	Name	Description
DRUG	Cetuximab	Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle.
DRUG	Cisplatin/Carboplatin	Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.
DRUG	5-fluorouracil	Participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.

Timeline

• Start date: 2015-07-31
• Primary completion: 2018-01-19
• Completion: 2021-12-20
• First posted: 2015-03-10
• Last updated: 2022-05-13
• Results posted: 2019-04-16

Locations

1 site across 1 country: Germany