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drugset / Trial / NCT04766359

Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma

NCT04766359 ↗

Phase 3 Unknown 364 enrolled The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RandomizedParallel-groupSingle-blindTreatment

Summary

This trial is a prospective, parallel controlled, randomized, open, multi-center phase III clinical trial. The trial will enroll 364 patients with nasopharyngeal carcinoma who are staged T1-2N0-1M0 (except T1N0M0) (UICC 8th edition) . This experiment was participated by multiple centers of Nanjing Gulou Hospital, Jiangsu Provincial People's Hospital, Jiangsu Cancer Hospital, Nanjing Military Region General Hospital, Jiangsu Provincial Hospital of Traditional Chinese Medicine, and Zhongda Hospital. Each center competes for admission of cases. The subjects will be randomly assigned (using the random number table method according to the order of entry) to the experimental group to receive albumin-bound paclitaxel combined with IMRT concurrent radiotherapy, or the control group to receive cisplatin combined with IMRT concurrent radiotherapy.

Timeline

Start
2021-03-01
Primary completion
2025-08-01
Completion
2025-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 40 mg/m2 Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous

Indications

nasopharyngeal carcinoma