NCT00508664

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: ClinAssess · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2007-07-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2007-07-30
• Last updated: 2015-06-02

Locations

27 sites across 2 countries: Austria, Germany