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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00508664
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : June 2, 2015
Sponsor:
Collaborators:
Merck Sharp & Dohme LLC
Sanofi
Information provided by (Responsible Party):
ClinAssess, University of Leipzig

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
Squamous Cell Carcinoma of the Hypopharynx Larynx Carcinoma Radiation: Radiation Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin (TP) Drug: 5-Fluorouracil (TPF) (only until Feb 2009) Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : July 2007
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


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 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: 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 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




Primary Outcome Measures :
  1. Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation [ Time Frame: LFS-rate 2 years after randomisation ]

Secondary Outcome Measures :
  1. Descriptive analysis of the study arms concerning the secondary end criteria of the study [ Time Frame: LSF 2 years after randomisation ]
  2. Explorative comparison of the study arms concerning the primary and secondary end criteria of the study [ Time Frame: LSF 2 years after randomisation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 < 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508664


Locations
Show Show 27 study locations
Sponsors and Collaborators
ClinAssess
Merck Sharp & Dohme LLC
Sanofi
Investigators
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Study Director: Andreas Dietz, Dr. med. University of Leipzig
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ClinAssess, Prof. Dietz, Universität Leipzig, University of Leipzig
ClinicalTrials.gov Identifier: NCT00508664    
Other Study ID Numbers: TP(F)+Radiation+/-Cetuximab
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2015
Keywords provided by ClinAssess, University of Leipzig:
by laryngectomy operable carcinoma of the larynx and the hypopharynx
Additional relevant MeSH terms:
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Carcinoma
Laryngeal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Docetaxel
Fluorouracil
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological