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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orlando Guntinas-Lichius, Prof. Dr. med.
• Treatments: Cisplatin; Docetaxel; Fluorouracil

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 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