Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005533

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005533
  •   2014/03/11
  •   2010/04/14
  •   yes
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Secondary IDs

  •   2009-011902-41 
  •   NCT01108042  (ClinicalTrials.gov)
  •   TISOC-1  (University of Jena)
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Health Condition or Problem studied

  •   Oropharynx Cancer
  •   Cavity of the Mouth Cancer
  •   C01 -  Malignant neoplasm of base of tongue
  •   C02 -  Malignant neoplasm of other and unspecified parts of tongue
  •   C03 -  Malignant neoplasm of gum
  •   C04 -  Malignant neoplasm of floor of mouth
  •   C05 -  Malignant neoplasm of palate
  •   C06 -  Malignant neoplasm of other and unspecified parts of mouth
  •   C10 -  Malignant neoplasm of oropharynx
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Interventions/Observational Groups

  •   Drug: Taxotere, Cisplatin, 5-FU
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
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Primary Outcome

- determination of progression-free survival after 2 years; time frame: 24 months

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2009/11/30
  •   86
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional 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

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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

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Addresses

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    • University of Jena
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    • Friedrich-Schiller-University Jena
    • Orlando Guntinas-Lichius, Prof. Dr. 
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    • Friedrich-Schiller-University Jena
    • Orlando Guntinas-Lichius, Prof. Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.