NCT01108042

TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer

Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Orlando Guntinas-Lichius, Prof. Dr. med. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the compatibility of the TPF-induction without decreasing the efficacy the dose will be given on day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks. In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will be defined. In the phase II-part the progression-free survival after 2 years will be assessed in patients treated with the optimal therapeutic dose.

Detailed description

Local advanced Oropharyngeal and cavity of the mouth Cancer are often treated with a combination of surgery and/or radiation and /or chemotherapy. Despite of therapy improvement there are only little advances in progression-free survival and overall survival. Therefore new therapy concepts are needed. The advantage of the induction chemotherapy is the possibility of tumor response assessment during chemotherapy and may present a selection criterion for organ preservation. In order to minimize the time between chemotherapy and surgery it is important to have an early answer for the tumor response. In this study response will be assessed after the first cycle of chemotherapy. Patients showing no tumor response will be operated at once. The other patients will receive further cycles of chemotherapy. Toxicity of the induction chemotherapy have to be moderate because surgery should not be delayed. To improve the tolerance of induction therapy the medication dose isn't given on day 1 every 3 weeks, but is dispersed on day 1 and day 8, q3weeks.

Conditions

• Oropharynx Cancer
• Squamous Cell Carcinoma of the Oral Cavity

Interventions

Type	Name	Description
DRUG	Taxotere, Cisplatin, 5-Fluorouracil (5-FU)	Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out. Phase 2: Optimal dose of phase 1 will be given.

Timeline

• Start date: 2009-11-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2010-04-21
• Last updated: 2016-05-18

Locations

4 sites across 1 country: Germany