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Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer

Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Oropharynx Cancer, Cavity of the Mouth Cancer

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Trial Information

Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer

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

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.

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

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

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determination of progression-free survival after 2 years

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Orlando Guntinas-Lichius, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Friedrich-Schiller-University Jena


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

November 2009

Completion Date:

June 2013

Related Keywords:

  • Oropharynx Cancer
  • Cavity of the Mouth Cancer
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms