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Trial record 67 of 11721 for:    Oral Cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01108042
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Orlando Guntinas-Lichius, Prof. Dr. med., University of Jena

Tracking Information
First Submitted Date  ICMJE April 14, 2010
First Posted Date  ICMJE April 21, 2010
Last Update Posted Date May 18, 2016
Study Start Date  ICMJE November 2009
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
Determination of progression-free survival after 2 years [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01108042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • Overall survival after 2 years [ Time Frame: after 2 years ]
  • Determination of the efficacy of the induction therapy [ Time Frame: after 1, 12 and 24 months ]
    CT or magnetic resonance tomography (MRT) of the neck region
  • Function of swallowing according the penetration-aspiration-scale [ Time Frame: 0,1, 6, 12, 18, 24 months ]
    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 ]
    The number of patients with adverse events will be evaluated. Adverse events will be assessed according Common Terminology Criteria of Adverse Events (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 ]
    European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ) for head and neck cancer patients (HN35) questionnaire filled in by the patients
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
  • Overall survival after 2 years [ Time Frame: after 2 years ]
  • Determination of the efficacy of the induction therapy [ Time Frame: after 1, 12 and 24 months ]
    CT or MRT of the neck region
  • Function of swallowing according the penetration-aspiration-scale [ Time Frame: 0,1, 6, 12, 18, 24 months ]
    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 ]
    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 ]
    EORTC QLQ-HN35 questionnaire filled in by the patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TPF-Induction Chemotherapy of Oropharyngeal and Cavity of the Mouth Cancer
Official Title  ICMJE Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Oropharynx Cancer
  • Squamous Cell Carcinoma of the Oral Cavity
Intervention  ICMJE 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.
Other Name: Docetaxel
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: Taxotere, Cisplatin, 5-Fluorouracil (5-FU)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2016)
71
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2010)
86
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 glutamate oxaloacetate transaminase (SGOT), glutamate pyruvate transaminase (SGPT) and bilirubin in normal range
  7. electrolytes in normal range
  8. risks of anesthesia complications normal or minor increased
  9. Eastern Cooperative Oncology Group (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 Innovation Center Computer Assisted Surgery (ICCAS) methods
  18. No prior chemotherapy or radiation (a primary 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01108042
Other Study ID Numbers  ICMJE TISOC-1
2009-011902-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Orlando Guntinas-Lichius, Prof. Dr. med., University of Jena
Study Sponsor  ICMJE Orlando Guntinas-Lichius, Prof. Dr. med.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Orlando Guntinas-Lichius, Prof. Dr. Friedrich-Schiller-University Jena
PRS Account University of Jena
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP