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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Larynge

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.

Detailed Summary:
Sponsor: ClinAssess

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

Original Primary Outcome: Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation

Current Secondary Outcome:

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


Original Secondary Outcome:

  • 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


Information By: University of Leipzig

Dates:
Date Received: July 27, 2007
Date Started: July 2007
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015