Study of the combination of gemcitabine, cetuximab and radiotherapy in patients with head and neck cancer - RAGE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017943-32-BE

Enrollment

Registered

2010-03-01

Start date

2010-05-31

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Histologically confirmed squamous cell carcinoma of the head and neck which qualifies for definitive treatment with chemoradiation MedDRA version: 12.1 Level: LLT Classification code 10067821 Term: Head and neck cancer

Interventions

Trade Name: Erbitux 5 mg/ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written and signed informed consent Histologically confirmed squamous cell carcinoma of the head and neck which qualifies for definitive treatment with chemoradiation Life expectancy of at least 12 weeks Age > 18 years Performance status of 0 or 1 according to the World Health Organization (WHO) Adequate hematologic, cardiac, pulmonary, renal and liver function 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnant or lactating women or women of childbearing potential without adequate contraceptive measures. Known brain or leptomeningeal metastasis Other serious medical conditions Congestive heart failure, uncontrolled angina pectoris, uncontrolled hypertension or uncontrolled arrhythmia Active infection History of significant neurologic or psychiatric disorders Known hypersensitivity reactions to cetuximab or gemcitabine or one of the excipients. Altered fractionation radiotherapy. Prior radiotherapy and/or chemotherapy (except as induction chemotherapy) within 6 months before enrolment

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the feasibility of the combination of weekly gemcitabine, weekly cetuximab and daily conventionally fractionated intensity modulated radiotherapy (IMRT) in patients with cancer of the head and neck. The combination will considered to be feasible if > 80 % of the patients can complete full radiation treatment without interruptions of > 7 days of radiation due to toxicity and if > 80 % of the patients can receive > 80 % of the planned total dose of cetuximab and gemcitabine.;Secondary Objective: To study the toxicity and safety profile of the combination of weekly gemcitabine, weekly cetuximab and daily IMRT in patients with cancer of the head and neck. To determine the time to locoregional relapse, the time to distant metastasis, progression free survival, time to progression, time to treatment failure and the overall survival. To determine the plasma levels of dFdU daily after the first administration of gemcitabine and before each weekly administration thereafter. To evaluate the quality of life before, during and after the treatment using EORTC QLQ-C30 and EORTC QLQ-H&N35. To determine the presence of HPV and p16 in tumor tissue. To determine the presence of EGFRvIII in tumor tissue. ;Primary end point(s): To study the feasibility of the combination of weekly gemcitabine, weekly cetuximab and daily conventionally fractionated intensity modulated radiotherapy (IMRT) in patients with cancer of the head and neck. The combination will considered to be feasible if > 80 % of the patients can complete full radiation treatment without interruptions of > 7 days of radiation due to toxicity and if > 80 % of the patients can receive > 80 % of the planned total dose of cetuximab and gemcitabine.	—

Measure

Time frame

Main Objective: To study the feasibility of the combination of weekly gemcitabine, weekly cetuximab and daily conventionally fractionated intensity modulated radiotherapy (IMRT) in patients with cancer of the head and neck. The combination will considered to be feasible if > 80 % of the patients can complete full radiation treatment without interruptions of > 7 days of radiation due to toxicity and if > 80 % of the patients can receive > 80 % of the planned total dose of cetuximab and gemcitabine.;Secondary Objective: To study the toxicity and safety profile of the combination of weekly gemcitabine, weekly cetuximab and daily IMRT in patients with cancer of the head and neck. To determine the time to locoregional relapse, the time to distant metastasis, progression free survival, time to progression, time to treatment failure and the overall survival. To determine the plasma levels of dFdU daily after the first administration of gemcitabine and before each weekly administration thereafter. To evaluate the quality of life before, during and after the treatment using EORTC QLQ-C30 and EORTC QLQ-H&N35. To determine the presence of HPV and p16 in tumor tissue. To determine the presence of EGFRvIII in tumor tissue. ;Primary end point(s): To study the feasibility of the combination of weekly gemcitabine, weekly cetuximab and daily conventionally fractionated intensity modulated radiotherapy (IMRT) in patients with cancer of the head and neck. The combination will considered to be feasible if > 80 % of the patients can complete full radiation treatment without interruptions of > 7 days of radiation due to toxicity and if > 80 % of the patients can receive > 80 % of the planned total dose of cetuximab and gemcitabine.

—

Countries

Belgium

Outcome results

None listed

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