CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
cisplatin and 5-Fu combined with nimotuzumabdrug
Likely dose
cisplatin and 5-Fu combined with nimotuzumab 100 mg/m2from 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/NCT01616849
NCT01616849Phase 2Completed
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Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma

Sun Yat-sen University·interventional·Posted Jun 12, 2012·Updated Sep 22, 2015

In Brief

A Phase 2 clinical trial evaluating cisplatin and 5-Fu combined with nimotuzumab for Stage IV Nasopharyngeal Carcinoma. Completed, enrolled 39 participants across 1 site.

Detailed Summary

This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage IV Nasopharyngeal Carcinoma
CountriesChina
CollaboratorsFujian Cancer Hospital, First People's Hospital of Foshan, People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi Medical University, Guangzhou Medical University, Hubei Cancer Hospital, Hunan Provincial Cancer Hospital, Hangzhou Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Jiangxi Provincial Cancer Hospital, Affiliated Cancer Hospital of Shantou University Medical College, Wuhan University, Zhejiang Cancer Hospital

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 12, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2015
TodayJul 1, 2026
Enrollment to primary: 3.2 yearsPosted 14.1 years ago

Interventions

cisplatin and 5-Fu combined with nimotuzumabdrug

DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks. Nimotuzumab 200mg/d, intravenous infusion every week