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Docetaxel, Cisplatin (TP) + Radiation +/- Cetuximab in Larynx Carcinoma (CA) (DeLOS II)

This study is currently recruiting participants.
Verified August 2010 by University of Leipzig
Sponsor:
Collaborators:
Merck
Sanofi
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00508664
First received: July 27, 2007
Last updated: August 4, 2011
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Squamous Cell Carcinoma of the Hypopharynx
Larynx Carcinoma
 Radiation: Radiation
Drug: Cetuximab
Drug: Docetaxel
Drug: Cisplatin (TP)
Drug: 5-Fluorouracil (TPF) (only until Feb 2009)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation [ Time Frame: LFS-rate 2 years after randomisation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Descriptive analysis of the study arms concerning the secondary end criteria of the study [ Time Frame: LSF 2 years after randomisation ] [ Designated as safety issue: No ]
  • Explorative comparison of the study arms concerning the primary and secondary end criteria of the study [ Time Frame: LSF 2 years after randomisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: July 2007
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
TP + Radiation (TPF until Feb 2009)
 Radiation: Radiation
Radiation start in week 11
Drug: Docetaxel
75 mg/m2 i.v. day 1 3 times
Other Name: Taxotere
Drug: Cisplatin (TP)
75 mg/m2 i.v. day 1 3 times
Drug: 5-Fluorouracil (TPF) (only until Feb 2009)
Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times
Experimental: B
TP + Cetuximab + Radiation (TPF until Feb 2009)
 Radiation: Radiation
Radiation start in week 11
Drug: Cetuximab
Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks
Drug: Docetaxel
75 mg/m2 i.v. day 1 3 times
Other Name: Taxotere
Drug: Cisplatin (TP)
75 mg/m2 i.v. day 1 3 times
Drug: 5-Fluorouracil (TPF) (only until Feb 2009)
Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508664

Contacts
Contact: Andreas Dietz, Dr. med. 49-341-972-1700 andreas.dietz@medizin.uni-leipzig.de

Locations
Austria
Universitätsklinik für HNO Recruiting
Graz, Austria, 8036
Contact: Sabine Reinisch, Univ. Ass. Dr.            
Contact: Michaela Salzwimmer, Dr. med.            
Principal Investigator: Sabine Reinisch, Univ. Ass. Dr.            
Landeskrankenhaus Klagenfurt Not yet recruiting
Klagenfurt, Austria, A-9020
Contact: Hans Eckel, Prof. Dr. med.            
Principal Investigator: Hans E Eckel, Prof. Dr. med.            
Allgemeines Krankenhaus der Stadt Wien Not yet recruiting
Vienna, Austria, 1090
Contact: Dietmar Thurnher, Univ.-Prof. Dr.            
Contact: Gabriela Kornek, Univ.-Prof. Dr.            
Principal Investigator: Martin Burian, Univ.-Prof. Dr.            
Germany
Medizinische Klinik I Prosper-Hospital Withdrawn
Recklinghausen, Nordrhein Westfalen, Germany, 45657
Helios Klinikum Erfurt GmbH Klinik für HNO-Heilkunde, Plastische Operationen Recruiting
Erfurt, Thüringen, Germany, 99089
Contact: Dirk Eßer, Prof. Dr. med.            
Contact: Sören Seeliger, Dr. med.            
Principal Investigator: Dirk Eßer, Prof. Dr. med.            
Universitätsklinik Aachen Recruiting
Aachen, Germany, 52074
Contact: Martin Westhofen, Prof. Dr. med.            
Principal Investigator: Martin Westhofen, Prof. Dr. med.            
Klinikum Neukölln, Vivantes GmbH Recruiting
Berlin, Germany, 12351
Contact: Volker Schilling, Dr. med.            
Contact: Petra Feyer, Prof. Dr. med.            
Principal Investigator: Volker Schilling, Dr. med.            
Charité, Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Ulrich Keilholz, Prof. Dr. med.            
Principal Investigator: Ulrich Keilholz, Prof. Dr. med.            
Klinikum Bielefeld-Mitte Recruiting
Bielefeld, Germany, 33604
Contact: Martin Görner, Dr. med.            
Principal Investigator: Martin Görner, Dr. med.            
Malteser Krankenhaus St. Anna gGmbH, HNO-Klinik Recruiting
Duisburg, Germany, 47259
Contact: Stefan Remmert, Prof. Dr. med.            
Contact: Julia Dahm, Dr. med.            
Principal Investigator: Stefan Remmert, Prof. Dr. med.            
Klinikum Fulda gAG, Klinik für Hals-Nasen-Ohrenkrankheiten Not yet recruiting
Fulda, Germany, 36043
Contact: Konrad Schwager, Prof. Dr. med.            
Principal Investigator: Konrad Schwager, Prof. Dr. med.            
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Martin Stieve, Dr. med.            
Principal Investigator: Martin Stieve, Dr. med.            
Klinikum Hannover Nordstadt Recruiting
Hannover, Germany
Contact: Hans-Jürgen Welkoborsky, Prof. Dr. med.            
Principal Investigator: Hans-Jürgen Welkoborsky, Prof. Dr. med.            
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Peter Plinkert, Prof. Dr. med.            
Principal Investigator: Peter Plinkert, Prof. Dr. med.            
Universitätsklinikum Jena Recruiting
Jena, Germany, 07743
Contact: Orlando Guntinas-Lichius, Prof. Dr. med.            
Principal Investigator: Orlando Guntinas-Lichius, Prof. Dr. med.            
Westpfalz-Klinikum GmbH Withdrawn
Kaiserslautern, Germany
St. Vincentius Kliniken Completed
Karlsruhe, Germany
Klinikum Kassel GmbH Recruiting
Kassel, Germany, 34125
Contact: Ulrike Bockmühl, Prof. Dr. med            
Principal Investigator: Ulrike Bockmühl, Prof. Dr. med.            
Katholisches Klinikum Koblenz Marienhof Not yet recruiting
Koblenz, Germany, 56073
Contact: Harald Gorgulla, Dr. med.            
Principal Investigator: Harald Gorgulla, Dr. med.            
Universitätsklinik Köln Recruiting
Köln, Germany, 50924
Contact: Markus Stenner, Dr. med.            
Principal Investigator: Markus Stenner, Dr. med.            
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Andreas Dietz, Prof. Dr. med.            
Principal Investigator: Andreas Dietz, Prof. Dr. med.            
Universtitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany, 23538
Contact: Ursula Schröder, Dr. med.            
Principal Investigator: Ursula Schröder, Dr. med.            
Klinikum Großhadern Recruiting
München, Germany, 81377
Contact: Phillip Baumeister, Dr. med.            
Contact: Uli Harreus, Dr. med.            
Principal Investigator: Phillip Baumeister, Dr. med.            
Medizinische Fakultät der Westfälischen Wilhelms-Universität Münster Recruiting
Münster, Germany, 48149
Contact: Claudia Rudack, Prof. Dr. med.            
Principal Investigator: Claudia Rudack, Prof. Dr. med.            
Südharz-Krankenhaus Nordhausen gGmbH Completed
Nordhausen, Germany
Klinikum Oldenburg gGmbH Withdrawn
Oldenburg, Germany, 26133
Klinikum Ernst von Bergmann gGmbH Recruiting
Potsdam, Germany, 14467
Contact: Georg Maschmeyer, Prof. Dr. med.            
Principal Investigator: Georg Maschmeyer, Prof. Dr. med.            
Universtitätsklinikum Regensburg Recruiting
Regensburg, Germany
Contact: Oliver Kölbl, Prof. Dr. med.            
Principal Investigator: Oliver Kölbl, Prof. Dr. med.            
Klinikum Stuttgart Katharinenhospital, Klinik für HNO-Krankheiten Recruiting
Stuttgart, Germany, 70174
Contact: Christian Sittel, Prof. Dr. med.            
Principal Investigator: Christian Sittel, Prof. Dr. med.            
Bayerischen Julius Maximillians-Universtät Würzburg Recruiting
Würzburg, Germany, 97080
Contact: Rudolph Hagen, Prof. Dr. med.            
Principal Investigator: Rudolph Hagen, Prof. Dr. med.            
Sponsors and Collaborators
University of Leipzig
Merck
Sanofi
Investigators
Study Director: Andreas Dietz, Dr. med. University of Leipzig
  More Information

No publications provided

Responsible Party: Prof. Andreas Dietz, University of Leipzig
ClinicalTrials.gov Identifier: NCT00508664     History of Changes
Other Study ID Numbers: TP(F)+Radiation+/-Cetuximab
Study First Received: July 27, 2007
Last Updated: August 4, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University of Leipzig:
by laryngectomy operable carcinoma of the larynx and the hypopharynx

Additional relevant MeSH terms:
Hypopharyngeal Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Laryngeal Diseases
Laryngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Neoplasms
Docetaxel
Cetuximab
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on May 16, 2013