Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005561

Trial Description

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Title

Randomised Phase II Screening Study to be Used in an TP/TPF-chemotherapy (Short Induction) Before TP/TPF-induction, Radiotherapy With or Without Cetuximab in the Primary Therapy of the Only by Laryngectomy Operable Carcinoma of the Larynx/Hypopharynx

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Trial Acronym

DeLOS II

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URL of the Trial

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Brief Summary in Lay Language

The DeLOS II trial is a multicenter randomised phase II trial investigating a
TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by
laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in
responder or non-responder after 4 weeks. Since August 2009 Responder receive TP with or
without Cetuximab + radiation. (Until february 2009 Responder received TPF with or without
Cetuximab + radiation.) Planned accrual is 85 patients per treatment arm. The primary study
endpoint is a confirmatory proof of an adequate survival rate with a functionally
larynx-conserving 2 years after randomisation.

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Brief Summary in Scientific Language

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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

  •   DRKS00005561
  •   2014/09/01
  •   2007/07/27
  •   yes
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Secondary IDs

  •   NCT00508664  (ClinicalTrials.gov)
  •   TP(F)+Radiation+/-Cetuximab  (University of Leipzig)
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Health Condition or Problem studied

  •   Squamous Cell Carcinoma of the Hypopharynx
  •   Larynx Carcinoma
  •   C13 -  Malignant neoplasm of hypopharynx
  •   C32 -  Malignant neoplasm of larynx
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Interventions/Observational Groups

  •   Radiation: Radiation
  •   Drug: Cetuximab
  •   Drug: Docetaxel
  •   Drug: Cisplatin (TP)
  •   Drug: 5-Fluorouracil (TPF) (only until Feb 2009)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation; time frame: LFS-rate 2 years after randomisation

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Secondary Outcome

- Descriptive analysis of the study arms concerning the secondary end criteria of the study; time frame: LSF 2 years after randomisation
- Explorative comparison of the study arms concerning the primary and secondary end criteria of the study; time frame: LSF 2 years after randomisation

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Countries of Recruitment

  •   Austria
  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2007/07/31
  •   170
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Histologically confirmed, primary only with laryngectomy respectable squamous-cell
carcinoma of the larynx or hypopharynx

- T3-T4a carcinoma of the glottis

- T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if
applicable by root of tongue segmental resection

- T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example
T2, post cricoidal) and hypopharynx segmental resection

- N-status: cervical metastases (N0-N3) have to be rehabilitate by surgical procedures

- Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes >
8000/ mm\3

- Clinical chemistry:

- adequate renal function, defined by serum creatinine and urea not higher than 25%
upper NL, creatinine-clearance > 60 ml/min/1,72 m\2

- adequate hepatic function with SGOT, SGPT not higher than 50% and bilirubin not
higher than upper NL

- electrolytes at NL

- anesthetic risk normal or low-grade elevated

- age 18-75 years

- written informed consent

- effective contraception after individual advice for men and women if there is a
possibility of reproductive potential (effective contraception are: oral
contraception with estrogen and gestagen (no minipill), vaginal ring,
contraception patch, estrogen free ovulation suppressors, hormone spiral with
progesterone, injection for three month with depot gestagen, hormone releasing
implantation (luteal hormone containing rod), abstinence or sterilization
(vasectomy) of the male)

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Exclusion Criteria

- primary cancer treatable by operational larynx -conserving procedures

- distant metastases (M1-Status)

- total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of
surrounding soft tissues respectively the esophageal aditus (exclusive cartilage
infiltration represents no exclusion criteria)

- tumor-specific prior chemo or radiotherapy

- metachronous or synchronous malignant tumor (exception basalioma) [in case of a
controlled tumor of different localization with a non-treated interval over 5 years
to the present therapy the patient can be included after consultation with the
coordinating investigator]

- life expectancy < 3 month

- Karnofsky performance status < 70%

- serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV
according NYHA status, myocardial infarction, angina pectoris, respiratory global
insufficiency)

- Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid
arthritis)

- recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any
other concomitant diseases, which disallow study participation in the opinion of the
responsible physician

- Other circumstances (contra-indications), which disallow treatment with Docetaxel,
Cisplatin, 5-FU, Cetuximab or radiotherapy

- Expected absent patient compliance

- Periodic follow-up not possible (for example address outside germany)

- Pregnant or breast-feeding woman

- Absent or constricted legal capacity

- Participation to another clinical trial with any investigational study within 30 days
prior to study screening

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Addresses

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    • University of Leipzig
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    • Merck
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    • Sanofi
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    • University of Leipzig
    • Andreas Dietz, Dr. med. 
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    • Andreas Dietz, Dr. med. 
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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 .
  •   2
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.