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Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab

NCT00941135 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2011-09-29

No results posted yet for this study

Summary

To evaluate the progression free time in patients with completed or partial response \> 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.

Conditions

  • Laryngeal Neoplasms

Interventions

OTHER

Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab

Docetaxel:75 mg/m2/d IV Cisplatin:75 mg/m2/d IV 5-FU:750 mg/m2/d IV TPF 3 cycles every 3 weeks Radiotherapy: Total 72 Gy in 42 fractions Cetuximab: 250 mg/m2/d Days 1, 8, 15, 22, 29, 36 and 43

Sponsors & Collaborators

  • Salutis Research, SL

    collaborator UNKNOWN

  • Unidad de Genética Clínica (Clínica Universitaria de Navarra)

    collaborator UNKNOWN

  • Fundacion Miguel Servet

    lead OTHER

Principal Investigators

  • Fernando Arias, MD · Hospital de Navarra

  • Ruth Vera, MD · Hospital de Navarra

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Spain

Study Locations

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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 NCT00941135 on ClinicalTrials.gov