A randomised study with Cisplatinum or Cetuximab and standard or adaptive high dose radiotherapy for advanced head and neck cancer

ARTFORCE - Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE. A randomised study with Cisplatinum or Cetuximab and standard or adaptive high dose radiotherapy for advanced head and neck cancer - ARTFORCE

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000437-39-ES

Enrollment

268

Registered

2012-03-13

Start date

2012-10-03

Completion date

Unknown

Last updated

2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Explore the impact of pre-treatment information and dose redistribution on locoregional control in patients with locally advanced SCCHN. ARREGLAR

Interventions

Trade Name: Erbitux Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMAB CAS Number: 205923-56-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stage III-IV, T3-4, SCC Head and Neck, 60, Performance status: WHO 0-1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68

Exclusion criteria

Exclusion criteria: Inability to receive one of the treatment arms, laryngeal cancer, known active symptomatic infections, prior surgery, radiotherapy or chemotherapy for this tumor

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effect and toxicity of concomitant chemoradiation or Cetuximab with standard dose distribution versus concomitant chemoradiation or Cetuximab with adaptive inhomogeneous dose distribution (redistribution) on locoregional progression free survival.;Secondary Objective: Zr89-Cetuximab uptake (on FDG-PET) predicts treatment-specific outcome.;Primary end point(s): 1. Locoregional recurrence-free survival at 2 years. 2. Correlation of anatomical distribution of ZR89-cetuximab uptake with treatment arm and anatomical location of recurrence 3. Toxicity Interim analysis on safety planned after 100 patients.;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To determine the effect and toxicity of concomitant chemoradiation or Cetuximab with standard dose distribution versus concomitant chemoradiation or Cetuximab with adaptive inhomogeneous dose distribution (redistribution) on locoregional progression free survival.;Secondary Objective: Zr89-Cetuximab uptake (on FDG-PET) predicts treatment-specific outcome.;Primary end point(s): 1. Locoregional recurrence-free survival at 2 years. 2. Correlation of anatomical distribution of ZR89-cetuximab uptake with treatment arm and anatomical location of recurrence 3. Toxicity Interim analysis on safety planned after 100 patients.;Timepoint(s) of evaluation of this end point: 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Quality of life during and after treatment, at 6 months and 1 yr. 2. Swallowing function preservation at 1 yr. 3. Progression-free survival, overall survival, toxicity.;Timepoint(s) of evaluation of this end point: 6 and 12 months	—

Countries

Netherlands, Spain

Contacts

Public ContactDr. Jordi Giralt

Dr. Jordi Giralt

jgiralt@vhebron.net349327461256086

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026