CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 180 enrolled
Drug / intervention
IMRT combine with cisplatin concurrent chemotherapy +1 moredrug
Likely dose
IMRT combine with cisplatin concurrent chemotherapy 100mg/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/NCT02143388
NCT02143388Phase 3Completed
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Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

Zhao Chong·interventional·Posted May 21, 2014·Updated Aug 31, 2022

In Brief

A Phase 3 clinical trial evaluating IMRT combine with cisplatin concurrent chemotherapy and IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy for Local Advanced High Risk Nasopharyngeal Carcinoma. Completed, enrolled 180 participants across 1 site.

Detailed Summary

This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocal Advanced High Risk Nasopharyngeal Carcinoma
CountriesChina
CollaboratorsJiangxi Provincial Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, National Cancer Centre, Singapore

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 21, 2014
Enrollment StartMar 31, 2014
Primary CompletionJul 27, 2018
Study CompletionAug 5, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.1 years ago

Interventions

IMRT combine with cisplatin concurrent chemotherapydrug

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapydrug

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.