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

NCT00508664 | Completed Phase 2

• 1 other identifier: TP(F)+Radiation+/-Cetuximab
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 27

Brief Summary

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.

Conditions

Squamous Cell Carcinoma of the Hypopharynx; Larynx Carcinoma

Keywords

by laryngectomy operable carcinoma of the larynx and the hypopharynx

Outcome Measures

Primary Outcomes (1)

• Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation

  LFS-rate 2 years after randomisation

Secondary Outcomes (2)

• Descriptive analysis of the study arms concerning the secondary end criteria of the study

  LSF 2 years after randomisation

• Explorative comparison of the study arms concerning the primary and secondary end criteria of the study

  LSF 2 years after randomisation

Study Arms (2)

A

EXPERIMENTAL

TP + Radiation (TPF until Feb 2009)

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

B

EXPERIMENTAL

TP + Cetuximab + Radiation (TPF until Feb 2009)

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

Interventions

Radiation RADIATION

Radiation start in week 11

A; B

Cetuximab DRUG

Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks

B

Docetaxel DRUG

75 mg/m2 i.v. day 1 3 times

Also known as: Taxotere

A; B

Cisplatin (TP) DRUG

75 mg/m2 i.v. day 1 3 times

A; B

5-Fluorouracil (TPF) (only until Feb 2009) DRUG

Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times

A; B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• primary cancer treatable by operational larynx -conserving procedures
• 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

Sponsors & Collaborators

• ClinAssess: lead
• Merck Sharp & Dohme LLC: collaborator
• Sanofi: collaborator

Study Sites (27)

Universitätsklinik für HNO

Graz, 8036, Austria

Location

Landeskrankenhaus Klagenfurt

Klagenfurt, A-9020, Austria

Location

Allgemeines Krankenhaus der Stadt Wien

Vienna, 1090, Austria

Location

Helios Klinikum Erfurt GmbH Klinik für HNO-Heilkunde, Plastische Operationen

Erfurt, Thuringia, 99089, Germany

Location

Universitätsklinik Aachen

Aachen, 52074, Germany

Location

Charité, Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Klinikum Neukölln, Vivantes GmbH

Berlin, 12351, Germany

Location

Klinikum Bielefeld-Mitte

Bielefeld, 33604, Germany

Location

Universitätsklinik Köln

Cologne, 50924, Germany

Location

Malteser Krankenhaus St. Anna gGmbH, HNO-Klinik

Duisburg, 47259, Germany

Location

Klinikum Fulda gAG, Klinik für Hals-Nasen-Ohrenkrankheiten

Fulda, 36043, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Klinikum Hannover Nordstadt

Hanover, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Jena

Jena, 07743, Germany

Location

St. Vincentius Kliniken

Karlsruhe, Germany

Location

Klinikum Kassel GmbH

Kassel, 34125, Germany

Location

Katholisches Klinikum Koblenz Marienhof

Koblenz, 56073, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universtitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Klinikum Großhadern

München, 81377, Germany

Location

Medizinische Fakultät der Westfälischen Wilhelms-Universität Münster

Münster, 48149, Germany

Location

Südharz-Krankenhaus Nordhausen gGmbH

Nordhausen, Germany

Location

Klinikum Ernst von Bergmann gGmbH

Potsdam, 14467, Germany

Location

Universtitätsklinikum Regensburg

Regensburg, Germany

Location

Klinikum Stuttgart Katharinenhospital, Klinik für HNO-Krankheiten

Stuttgart, 70174, Germany

Location

Bayerischen Julius Maximillians-Universtät Würzburg

Würzburg, 97080, Germany

Location

Related Publications (1)

• 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.

  PMID: 30412221 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms

Interventions

Radiation; Cetuximab; Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andreas Dietz, Dr. med.

  University of Leipzig

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dietz, Universität Leipzig

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 30, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

DE (24); AU (3)