Oropharynx Cancer Clinical Trial
Official title:
Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer
Verified date | May 2016 |
Source | University of Jena |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | February 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Städt. Kliniken Bielefeld gem. GmbH | Bielefeld | |
Germany | Friedrich-Schiller-University Jena | Jena | |
Germany | Universitätsklinikum Leipzig - Klinik und Poliklinik für HNO-Heilkunde | Leipzig | |
Germany | Klinikum Ernst von Bergmann | Potsdam |
Lead Sponsor | Collaborator |
---|---|
Orlando Guntinas-Lichius, Prof. Dr. med. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of progression-free survival after 2 years | 24 months | No | |
Secondary | Overall survival after 2 years | after 2 years | No | |
Secondary | Determination of the efficacy of the induction therapy | CT or magnetic resonance tomography (MRT) of the neck region | after 1, 12 and 24 months | No |
Secondary | Function of swallowing according the penetration-aspiration-scale | assessed according the penetration-aspiration-scale (PAS, Rosenbek et al. 1996) and according measuring after Prosiegel (Prosiegel et al. 2002). | 0,1, 6, 12, 18, 24 months | Yes |
Secondary | Adverse events as a measure of safety and tolerability | 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. | once a week | Yes |
Secondary | Quality of life | 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 | 0,1, 6, 12, 18, 24 months | Yes |
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