Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00609284

Acronym

2007-01

Enrollment

406

Registered

2008-02-07

Start date

2008-02-15

Completion date

2019-03-26

Last updated

2020-04-15

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

Conditions

HNSCC

Keywords

Stage III, Stage IV, locally advanced

Brief summary

The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.

Interventions

DRUGcetuximab

D-7, D1, D8, D15, D22, D29, D43, D50

DRUGCarboplatin, 5FU concomitant

Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46

RADIATIONRadiotherapy

70 Gy in 7 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx * Stage III - IV (T0-T4, N0-N2b, M0) * Not resected * Karnofsky PS\>=80 * Informed consent signed

Exclusion criteria

* Contra indication to chemotherapy or cetuximab

Design outcomes

Primary

Measure	Time frame
Progression free survival	3 years

Secondary

Measure	Time frame
Loco-regional control	3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026