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

NCT00508664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-06-02

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Andreas Dietz, Dr. med. · University of Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Austria
  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00508664 on ClinicalTrials.gov