NCT03117257

Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN

A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Guiyang Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.

Detailed description

TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients. Therefore, how to improve the efficacy of the same time to reduce adverse drug reactions, as a prominent problem. Lobaplatin as the third generation of platinum antitumor drugs, anti-cancer activity and cisplatin rather, more than carboplatin. In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.

Conditions

• Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Lobaplatin	Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
DRUG	Cisplatin	Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy

Timeline

• Start date: 2016-08-19
• Primary completion: 2019-08-19
• Completion: 2021-08-20
• First posted: 2017-04-17
• Last updated: 2017-04-17

Locations

1 site across 1 country: China