Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer
18 Years
80 Years
Both
Oropharynx Cancer, Cavity of the Mouth Cancer
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
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.
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
Type of Study:
Interventional
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:
No
Principal Investigator
Orlando Guntinas-Lichius, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Friedrich-Schiller-University Jena
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
TISOC-1
NCT ID:
NCT01108042
Start Date:
November 2009
Completion Date:
June 2013
Related Keywords:
- Oropharynx Cancer
- Cavity of the Mouth Cancer
- Mouth Neoplasms
- Oropharyngeal Neoplasms
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