Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

Phase 3 Unknown 400 enrolled Zhejiang Cancer Hospital Second Affiliated Hospital, School of Medicine, Zhejiang University · collab Sir Run Run Shaw Hospital · collab Wenzhou Medical University · collab Zhejiang Provincial People's Hospital · collab Zhejiang University · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.

Timeline

Start: 2012-04
Primary completion: 2013-12
Completion: 2015-02

Outcome

Missed primary endpoint

paper a PFS benefit was observed for TPF compared to PF, though this difference was not statistically significant (84.5% vs. 77.9%, P = .380). PMID 30797141 ↗

Publications

Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. doi: 10.1016/j.tranon.2019.01.002. Epub 2019 Feb 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cisplatin	Other / unclassified	75 mg/m2	—
Comparator	Cisplatin	Other / unclassified	80 mg/m2	—
Comparator	Cisplatin	Other / unclassified	100 mg/m2	—
Subject	Docetaxel	Small molecule	75 mg/m2	—
Comparator	fluorouracil	Small molecule	2400 mg/m2	Intravenous
Comparator	fluorouracil	Small molecule	4000 mg/m2	Intravenous