CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 243 enrolled
Drug / intervention
Cetuximab +2 moredrug
Likely dose
Cetuximab 400 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02383966
NCT02383966Phase 3Completed
CompareCT.gov

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

Merck KGaA, Darmstadt, Germany·interventional·Posted Mar 10, 2015·Updated May 13, 2022

In Brief

A Phase 3 clinical trial evaluating Cetuximab, Cisplatin/Carboplatin, and 1 other intervention for Carcinoma, Squamous Cell of Head and Neck. Completed, enrolled 243 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Squamous Cell of Head and Neck
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 10, 2015
Enrollment StartJul 31, 2015
Primary CompletionJan 19, 2018
Study CompletionDec 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.3 years ago

Interventions

Cetuximabdrug

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.

Cisplatin/Carboplatindrug

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.

5-fluorouracildrug

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.