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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Sanofi
Information provided by (Responsible Party):
ClinAssess, University of Leipzig
ClinicalTrials.gov Identifier:
NCT00508664
First received: July 27, 2007
Last updated: January 23, 2014
Last verified: January 2014

July 27, 2007
January 23, 2014
July 2007
October 2014   (final data collection date for primary outcome measure)
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 ]
Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation
Complete list of historical versions of study NCT00508664 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Descriptive analysis of the study arms concerning the secondary end criteria of the study
  • Explorative comparison of the study arms concerning the primary and secondary end criteria of the study
Not Provided
Not Provided
 
Docetaxel, Cisplatin (TP) + Radiation +/- Cetuximab in Larynx Carcinoma (CA)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Squamous Cell Carcinoma of the Hypopharynx
  • Larynx Carcinoma
  • 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
  • Experimental: A
    TP + Radiation (TPF until Feb 2009)
    Interventions:
    • Radiation: Radiation
    • Drug: Docetaxel
    • Drug: Cisplatin (TP)
    • Drug: 5-Fluorouracil (TPF) (only until Feb 2009)
  • Experimental: B
    TP + Cetuximab + Radiation (TPF until Feb 2009)
    Interventions:
    • Radiation: Radiation
    • Drug: Cetuximab
    • Drug: Docetaxel
    • Drug: Cisplatin (TP)
    • Drug: 5-Fluorouracil (TPF) (only until Feb 2009)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
Not Provided
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00508664
TP(F)+Radiation+/-Cetuximab
No
ClinAssess, University of Leipzig
ClinAssess
  • Merck Sharp & Dohme Corp.
  • Sanofi
Study Director: Andreas Dietz, Dr. med. University of Leipzig
University of Leipzig
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP