CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 352 target
Drug / intervention
Docetaxel, nedaplatin, fluorouracil +4 moredrug
Likely dose
Docetaxel, nedaplatin, fluorouracil 60 mg/m2from record
Key inclusion· 5
  • Newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, WHO II or III
  • Stage III-IVa (except T3-4N0) by 8th edition AJCC
  • No distant metastasis (M0)
  • Age 18-65 years
Key exclusion· 7
  • Keratinizing nasopharyngeal carcinoma (WHO I)
  • Age <18 or >65 years
  • Palliative intent treatment
  • Prior malignancy except skin cancer or in situ cervical cancer

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

Search/NCT04437329
NCT04437329Phase 3RecruitingOn TrackUpdated 49mo ago
Long Recruiting

Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma:a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study

Affiliated Cancer Hospital & Institute of Guangzhou Medical University·interventional·Posted Jun 18, 2020·Updated May 10, 2022

In Brief

A Phase 3 clinical trial evaluating Docetaxel, nedaplatin, fluorouracil, Docetaxel, cisplatin, fluorouracil, and 3 other interventions for Nasopharyngeal Carcinoma. Currently recruiting, targeting 352 participants across 1 site.

Detailed Summary

To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
202120222023202420252026202720282029
First PostedJun 18, 2020
Enrollment StartAug 1, 2020
Primary CompletionJun 30, 2028
Study CompletionJun 30, 2029
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 6.0 years agoPrimary completion in 2.0 years

Interventions

Docetaxel, nedaplatin, fluorouracildrug

Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.

Docetaxel, cisplatin, fluorouracildrug

Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.

Nedaplatindrug

Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.

Cisplatindrug

Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.

Intensity modulated-radiotherapyradiation

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.