Docetaxel, Cisplatin (TP) + Radiation +/- Cetuximab in Larynx Carcinoma (CA)
NCT ID: NCT00508664
Last Updated: 2015-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2007-07-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
TP + Radiation (TPF until Feb 2009)
Radiation
Radiation start in week 11
Docetaxel
75 mg/m2 i.v. day 1 3 times
Cisplatin (TP)
75 mg/m2 i.v. day 1 3 times
5-Fluorouracil (TPF) (only until Feb 2009)
Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times
B
TP + Cetuximab + Radiation (TPF until Feb 2009)
Radiation
Radiation start in week 11
Cetuximab
Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks
Docetaxel
75 mg/m2 i.v. day 1 3 times
Cisplatin (TP)
75 mg/m2 i.v. day 1 3 times
5-Fluorouracil (TPF) (only until Feb 2009)
Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times
Interventions
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Radiation
Radiation start in week 11
Cetuximab
Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks
Docetaxel
75 mg/m2 i.v. day 1 3 times
Cisplatin (TP)
75 mg/m2 i.v. day 1 3 times
5-Fluorouracil (TPF) (only until Feb 2009)
Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* distant metastases (M1-Status)
* 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
18 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Sanofi
INDUSTRY
ClinAssess
OTHER
Responsible Party
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ClinAssess
Prof. Dietz, Universität Leipzig
Principal Investigators
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Andreas Dietz, Dr. med.
Role: STUDY_DIRECTOR
University of Leipzig
Locations
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Universitätsklinik für HNO
Graz, , Austria
Landeskrankenhaus Klagenfurt
Klagenfurt, , Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
Helios Klinikum Erfurt GmbH Klinik für HNO-Heilkunde, Plastische Operationen
Erfurt, Thuringia, Germany
Universitätsklinik Aachen
Aachen, , Germany
Charité, Campus Benjamin Franklin
Berlin, , Germany
Klinikum Neukölln, Vivantes GmbH
Berlin, , Germany
Klinikum Bielefeld-Mitte
Bielefeld, , Germany
Universitätsklinik Köln
Cologne, , Germany
Malteser Krankenhaus St. Anna gGmbH, HNO-Klinik
Duisburg, , Germany
Klinikum Fulda gAG, Klinik für Hals-Nasen-Ohrenkrankheiten
Fulda, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum Hannover Nordstadt
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Jena
Jena, , Germany
St. Vincentius Kliniken
Karlsruhe, , Germany
Klinikum Kassel GmbH
Kassel, , Germany
Katholisches Klinikum Koblenz Marienhof
Koblenz, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universtitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Klinikum Großhadern
München, , Germany
Medizinische Fakultät der Westfälischen Wilhelms-Universität Münster
Münster, , Germany
Südharz-Krankenhaus Nordhausen gGmbH
Nordhausen, , Germany
Klinikum Ernst von Bergmann gGmbH
Potsdam, , Germany
Universtitätsklinikum Regensburg
Regensburg, , Germany
Klinikum Stuttgart Katharinenhospital, Klinik für HNO-Krankheiten
Stuttgart, , Germany
Bayerischen Julius Maximillians-Universtät Würzburg
Würzburg, , Germany
Countries
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References
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Dietz A, Wichmann G, Kuhnt T, Pfreundner L, Hagen R, Scheich M, Kolbl O, Hautmann MG, Strutz J, Schreiber F, Bockmuhl U, Schilling V, Feyer P, de Wit M, Maschmeyer G, Jungehulsing M, Schroeder U, Wollenberg B, Sittel C, Munter M, Lenarz T, Klussmann JP, Guntinas-Lichius O, Rudack C, Eich HT, Foerg T, Preyer S, Westhofen M, Welkoborsky HJ, Esser D, Thurnher D, Remmert S, Sudhoff H, Gorner M, Bunzel J, Budach V, Held S, Knodler M, Lordick F, Wiegand S, Vogel K, Boehm A, Flentje M, Keilholz U. Induction chemotherapy (IC) followed by radiotherapy (RT) versus cetuximab plus IC and RT in advanced laryngeal/hypopharyngeal cancer resectable only by total laryngectomy-final results of the larynx organ preservation trial DeLOS-II. Ann Oncol. 2018 Oct 1;29(10):2105-2114. doi: 10.1093/annonc/mdy332.
Other Identifiers
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TP(F)+Radiation+/-Cetuximab
Identifier Type: -
Identifier Source: org_study_id
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