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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Jena.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01108042
First received: April 14, 2010
Last updated: June 28, 2010
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Oropharynx Cancer
Cavity of the Mouth Cancer
Drug: Taxotere, Cisplatin, 5-FU
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • determination of progression-free survival after 2 years [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival after 2 years [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
  • Determination of the efficacy of the induction therapy [ Time Frame: after 1, 12 and 24 months ] [ Designated as safety issue: No ]
    CT or MRT of the neck region

  • function of swallowing according the penetration-aspiration-scale [ Time Frame: 0,1, 6, 12, 18, 24 months ] [ Designated as safety issue: Yes ]
    assessed according the penetration-aspiration-scale (PAS, Rosenbek et al. 1996) and according measuring after Prosiegel (Prosiegel et al. 2002).

  • Adverse events as a measure of safety and tolerability [ Time Frame: once a week ] [ Designated as safety issue: Yes ]
    The number of patients with adverse events will be evaluated. Adverse events will be assessed according CTCAE v.3.0 and analysed as number per patient and number per cycle.

  • Quality of life [ Time Frame: 0,1, 6, 12, 18, 24 months ] [ Designated as safety issue: Yes ]
    EORTC QLQ-HN35 questionnaire filled in by the patients


Estimated Enrollment: 86
Study Start Date: November 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infusion: Taxotere, Cisplatin, 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.
Drug: Taxotere, Cisplatin, 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.
Other Name: Docetaxel

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological proven, resectable squamous epithelial carcinoma of the oropharynx and the cavity of the mouth
  2. R0-resection possible
  3. All T N2 M0 / all T N3 M0 / if T3 or T4a also N0-1 M0
  4. Leucocytes > 4000/mm³ bzw. neutrophils > 2000/mm³, thrombocytes > 100000/mm³
  5. adequate kidney function, defined as serum creatinine und urea in normal range, Creatinine clearance > 60 ml/min
  6. adequate liver function with SGOT, SGPT and bilirubin in normal range
  7. electrolytes in normal range
  8. risks of anesthesia complications normal or minor increased
  9. ECOG 0-2 / Karnofsky >= 60%
  10. Age 18 - 80 years
  11. signed written informed consent
  12. effective contraception for both male and female subjects if the risk of conception exists

    Exclusion Criteria:

  13. T1 N0 M0 / T1 N1 M0 / T2 N0 M0 / T2 N1 M0
  14. Resection without curative intention: primary tumor is not treatable with resection methods
  15. Infiltration of the lower jaw
  16. M1 status
  17. Tumor not measurable with ICCAS methods
  18. No prior chemotherapy or radiation (a primäry surgery is allowed)
  19. Metachronous or oder synchronous malignoma (Exception: basal cell carcinoma)
  20. Life expectance < 3 months
  21. ECOG > 2; Karnofsky < 60%
  22. acute infections or fever
  23. known HIV-infection or other immune suppression
  24. severe cardio pulmonary concomitant diseases
  25. chronic disease with continuous therapy (uncontrolled diabetes, rheumatoid arthritis) especially continuous therapy with steroids
  26. other concomitant diseases which, in the investigator's opinion, would exclude the patient from the study
  27. Contraindications which permit a therapy with Docetaxel, Cisplatin, 5-FU or radiation therapy
  28. missing patient's compliance
  29. regular Follow-up visits not possible
  30. Pregnancy or lactation period
  31. legal incapacity or limited legal capacity
  32. Participation in another clinical trial or administration of a not approved substance within 30 days before registration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108042

Locations
Germany
Städt. Kliniken Bielefeld gem. GmbH Active, not recruiting
Bielefeld, Germany, 33604
Friedrich-Schiller-University Jena Recruiting
Jena, Germany, 07740
Contact: Orlando Guntinas-Lichius, Prof. Dr.    +49 (0)3641-935127    Orlando.Guntinas@med.uni-jena.de   
Sub-Investigator: Claus Wittekindt, PD Dr. med.         
Universitätsklinikum Leipzig - Klinik und Poliklinik für HNO-Heilkunde Active, not recruiting
Leipzig, Germany, 04103
Klinikum Ernst von Bergmann Active, not recruiting
Potsdam, Germany, 14467
Sponsors and Collaborators
University of Jena
Investigators
Principal Investigator: Orlando Guntinas-Lichius, Prof. Dr. Friedrich-Schiller-University Jena
  More Information

No publications provided by University of Jena

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Orlando Guntinas-Lichius, Friedrich-Schiller-University Jena, Medical Faculty
ClinicalTrials.gov Identifier: NCT01108042     History of Changes
Other Study ID Numbers: TISOC-1, 2009-011902-41
Study First Received: April 14, 2010
Last Updated: June 28, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Mouth Neoplasms
Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014