Clincosm LogoSign in Get a demo

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

Sponsor
ClinAssess (Other)
Overall Status
Completed
CT.gov ID
NCT00508664
Collaborator
Merck Sharp & Dohme LLC (Industry), Sanofi (Industry)
180
Enrollment
27
Locations
2
Arms
91.1
Duration (Months)
6.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation [LFS-rate 2 years after randomisation]

    Secondary Outcome Measures

    1. Descriptive analysis of the study arms concerning the secondary end criteria of the study [LSF 2 years after randomisation]

    2. Explorative comparison of the study arms concerning the primary and secondary end criteria of the study [LSF 2 years after randomisation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Universitätsklinik für HNO Graz Austria 8036
    2 Landeskrankenhaus Klagenfurt Klagenfurt Austria A-9020
    3 Allgemeines Krankenhaus der Stadt Wien Vienna Austria 1090
    4 Helios Klinikum Erfurt GmbH Klinik für HNO-Heilkunde, Plastische Operationen Erfurt Thüringen Germany 99089
    5 Universitätsklinik Aachen Aachen Germany 52074
    6 Charité, Campus Benjamin Franklin Berlin Germany 12200
    7 Klinikum Neukölln, Vivantes GmbH Berlin Germany 12351
    8 Klinikum Bielefeld-Mitte Bielefeld Germany 33604
    9 Malteser Krankenhaus St. Anna gGmbH, HNO-Klinik Duisburg Germany 47259
    10 Klinikum Fulda gAG, Klinik für Hals-Nasen-Ohrenkrankheiten Fulda Germany 36043
    11 Medizinische Hochschule Hannover Hannover Germany 30625
    12 Klinikum Hannover Nordstadt Hannover Germany
    13 Universitätsklinikum Heidelberg Heidelberg Germany 69120
    14 Universitätsklinikum Jena Jena Germany 07743
    15 St. Vincentius Kliniken Karlsruhe Germany
    16 Klinikum Kassel GmbH Kassel Germany 34125
    17 Katholisches Klinikum Koblenz Marienhof Koblenz Germany 56073
    18 Universitätsklinik Köln Köln Germany 50924
    19 Universitätsklinikum Leipzig Leipzig Germany 04103
    20 Universtitätsklinikum Schleswig-Holstein Lübeck Germany 23538
    21 Klinikum Großhadern München Germany 81377
    22 Medizinische Fakultät der Westfälischen Wilhelms-Universität Münster Münster Germany 48149
    23 Südharz-Krankenhaus Nordhausen gGmbH Nordhausen Germany
    24 Klinikum Ernst von Bergmann gGmbH Potsdam Germany 14467
    25 Universtitätsklinikum Regensburg Regensburg Germany
    26 Klinikum Stuttgart Katharinenhospital, Klinik für HNO-Krankheiten Stuttgart Germany 70174
    27 Bayerischen Julius Maximillians-Universtät Würzburg Würzburg Germany 97080

    Sponsors and Collaborators

    • ClinAssess
    • Merck Sharp & Dohme LLC
    • Sanofi

    Investigators

    • Study Director: Andreas Dietz, Dr. med., University of Leipzig

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ClinAssess, Prof. Dietz, Universität Leipzig, University of Leipzig
    ClinicalTrials.gov Identifier:
    NCT00508664
    Other Study ID Numbers:
    • TP(F)+Radiation+/-Cetuximab
    First Posted:
    Jul 30, 2007
    Last Update Posted:
    Jun 2, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by ClinAssess, Prof. Dietz, Universität Leipzig, University of Leipzig
    by laryngectomy operable carcinoma of the larynx and the hypopharynx
    Additional relevant MeSH terms:
    Carcinoma
    Laryngeal Diseases
    Docetaxel
    Fluorouracil
    Cetuximab

    Study Results

    No Results Posted as of Jun 2, 2015