drugset / Trial / NCT03558035

New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

NCT03558035 ↗

Phase 2 Unknown 96 enrolled Chinese Academy of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.

Timeline

Start
2014-09
Primary completion
2021-02
Completion
2021-03

Outcome

Missed primary endpoint

paper The 3-year OS was 53.1% in the IC + CCRT group compared with 54.8% in the CCRT group (hazard ratio, 1.004; 95% confidence interval, 0.573-1.761; P = 0.988). PMID 36447152 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 80 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject fluorouracil Small molecule 750 mg/m2 Intravenous