TPF + Radiation +/- Cetuximab in Larynx CA/ DeLOS II - Full Text View

Sponsors and Collaborators:	University of Leipzig Merck Sanofi-Aventis
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00508664

Purpose

The DeLOS II trial is a multicenter randomised phase II trial investigating a 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. Responder receive 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 Drug: 5-Fluorouracil	Phase II

Drug Information available for: Docetaxel Cisplatin Fluorouracil Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Randomised Phase II Screening Study to be Used in an TPF-Chemotherapy (Short Induction) Before TPF-Induction, Radiotherapy With or Without Cetuximab in the Primary Therapy of the Only by Laryngectomy Operable Carcinoma of the Larynx/Hypopharynx.

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 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention TPF+Radiation	Radiation: Radiation radiation start in week 11 Drug: Docetaxel 75 mg/m2 i.v. day 1 3 times Drug: Cisplatin 75 mg/m2 i.v. day 1 3 times Drug: 5-Fluorouracil 750 mg/m2 i.v. day 1-5 3 times
B: Experimental TPF+Cetuximab+Radiation	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 Drug: Cisplatin 75 mg/m2 i.v. day 1 3 times Drug: 5-Fluorouracil 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 < 60%
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)
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
Landeskrankenhaus Klagenfurt	Not yet recruiting
Klagenfurt, Austria, A-9020
Contact: Hans Eckel, Prof. Dr. med.
Principal Investigator: Hans Edmund, Prof. Dr. med.
Germany
Klinikum Neukölln, Vivantes GmbH	Not yet recruiting
Berlin, Germany, 12351
Contact: Volker Schilling, Dr. med.
Contact: Petra Feyer, Prof. Dr. med.
Principal Investigator: Volker Schilling, Dr. med.
Heinrich-Heine-Universität	Not yet recruiting
Düsseldorf, Germany, 40225
Contact: Henning August Bier, Prof. Dr. med
Principal Investigator: Henning August Bier, Prof. Dr. med
Klinikum Großhadern	Not yet recruiting
München, Germany, 81377
Contact: Uli Harreus, Dr. med.
Principal Investigator: Uli Harreus, Dr. med.
Medizinische Hochschule Hannover	Not yet recruiting
Hannover, Germany, 30625
Contact: Martin Stieve, Dr. med.
Principal Investigator: Martin Stieve, Dr. med.
St. Vincentius Kliniken Karlsruhe	Recruiting
Karlsruhe, Germany, 76135
Contact: Bernard Vanlesow, Dr. med.
Principal Investigator: Bernard Vanselow, Dr. med.
Klinikum Kassel GmbH	Not yet recruiting
Kassel, Germany, 34125
Contact: Michael Schröder, Prof. Dr. med
Principal Investigator: Michael Schröder, Prof. Dr. med.
Phillipps Universität Marburg	Not yet recruiting
Marburg, Germany, 35037
Contact: Jochen Alfred Werner, Prof. Dr. med.
Principal Investigator: Jochen Alfred Werner, Prof. Dr. med.
Klinikum Oldenburg gGmbH	Not yet recruiting
Oldenburg, Germany, 26133
Contact: Florian Hoppe, Prof. Dr. med.
Principal Investigator: Florian Hoppe, Prof. Dr. med.
Medizinische Fakultät der Westfälischen Wilhelms-Universität Münster	Not yet recruiting
Münster, Germany, 48149
Contact: Claudia Rudack, Prof. Dr. med.
Principal Investigator: Claudia Rudack, Prof. Dr. med.
Universitätsklinikum Jena	Recruiting
Jena, Germany, 07743
Contact: Orlando Guntinas-Lichius, Prof. Dr. med.
Principal Investigator: Orlando Guntinas-Lichius, Prof. Dr. med.
Universitätsklinik Aachen	Not yet recruiting
Aachen, Germany, 52074
Contact: Yue-Shih Chen, Dr. med.
Principal Investigator: Yue-Shih Chen, Dr. med.
Universitätsklinikum Heidelberg	Not yet recruiting
Heidelberg, Germany, 69120
Contact: Peter Plinkert, Prof. Dr. med.
Principal Investigator: Peter Plinkert, Prof. Dr. med.
Universitätsklinik Erlangen	Not yet recruiting
Erlangen, Germany, 91054
Contact: Heinrich Iro, Prof. Dr. med.
Principal Investigator: Heinrich Iro, Prof. Dr. med.
Universitätsklinik Köln	Not yet recruiting
Köln, Germany, 50924
Contact: Jens Peter Klussmann, Dr. med.
Principal Investigator: Jens Peter Klussmann, Dr. med.
Klinikum Ernst von Bergmann gGmbH	Recruiting
Potsdam, Germany, 14467
Contact: Georg Maschmeyer, Prof. Dr. med.
Principal Investigator: Georg Maschmeyer, Prof. Dr. med.
Charité, Campus Benjamin Franklin	Not yet recruiting
Berlin, Germany, 12200
Contact: Ulrich Keilholz, Prof. Dr. med.
Principal Investigator: Ulrich Keilholz, Prof. Dr. med.
Bayerischen Julius Maximillians-Universtät Würzburg	Not yet recruiting
Würzburg, Germany, 97080
Contact: Rudolph Hagen, Prof. Dr. med.

Sponsors and Collaborators

University of Leipzig

Merck

Sanofi-Aventis

Investigators

Study Director:

Andreas Dietz, Dr. med.

University of Leipzig

More Information

Responsible Party:	University of Leipzig ( Prof. Andreas Dietz )
Study ID Numbers:	TPF+Radiation+/-Cetuximab
Study First Received:	July 27, 2007
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00508664
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:

by laryngectomy operable carcinoma of the larynx and the hypopharynx

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Squamous cell carcinoma
Cetuximab
Pharyngeal Neoplasms
Pharyngeal Diseases
Carcinoma
Docetaxel
Epidermoid carcinoma
Hypopharyngeal Neoplasms

Cisplatin
Fluorouracil
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Neoplasms, Squamous Cell
Stomatognathic Diseases
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009