Trial intelligence / Profile preview

Neoadjuvant TPF and Concomitant Cetuximab/Chemo-RT in Head and Neck Cancer

NCT01086826Phase 3

Key facts

Status: Completed
Start: Mar 2008
Primary completion: Apr 2014
Countries: 1
Sponsor: Associazione Volontari Pazienti Oncologici
Modality: Small Molecules, Monoclonal Antibodies

Drugs: docetaxelKL-140
Conditions: head and neck squamous cell carcinoma (HNSCC)

Overview

Phase 3, randomised, open-label trial of docetaxel and KL-140 in head and neck squamous cell carcinoma (HNSCC) (4 arms), sponsored by Associazione Volontari Pazienti Oncologici. Primary endpoint: Overall Survival at 3 years. Started Mar 2008; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

RT+CDDP/5-FU
Radiotherapy with concomitant Cisplatin and 5-FU
RT+CETUXIMAB
Radiotherapy with concomitant Cetuximab
INDUCTION TPF + RT+CDDP/5-FU
Induction TPF followed by Radiotherapy with concomitant Cisplatin and 5-FU
INDUCTION TPF + RT+CETUXIMAB
Induction TPF followed by Radiotherapy with concomitant Cetuximab

Who it enrols

Patients with locally advanced (Stage III/IV) squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx) who are inoperable or have low surgical curability, with good performance status and organ function.

Endpoints

Primary

Overall Survival3 years

Secondary

Progression Free Survival3 years

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