MedTrace Logo

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

NCT01108042 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2016-05-18

No results posted yet for this study

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.

Conditions

  • Oropharynx Cancer
  • Squamous Cell Carcinoma of the Oral Cavity

Interventions

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.

Sponsors & Collaborators

  • Orlando Guntinas-Lichius, Prof. Dr. med.

    lead OTHER

Principal Investigators

  • Orlando Guntinas-Lichius, Prof. Dr. · Friedrich-Schiller-University Jena

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2016-01-31
Completion
2016-02-29

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01108042 on ClinicalTrials.gov