Status:
COMPLETED
Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck.
Detailed Description
Advanced squamous cell carcinoma of the head and neck still has a poor prognosis and loco-regional recurrence frequently occurs. Efforts have been made to improve response rates and survival and diffe...
Eligibility Criteria
Inclusion
- Signed written informed consent;
- Males or females between 18 and 70 years of age;
- Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than 6-9 weeks (maximum) ago;
- To be categorized as high risk patients have to fulfil at least one of the following criteria:
- R0 - resection \<5 mm margin
- R1 - resection
- Extracapsular nodal extension;
- no previous chemotherapy, radiotherapy;
- Performance status ECOG: 0 - 1;
- Contraception in male and female patients if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing;
- Adequate renal, liver and hematological functions (within maximum 9 weeks until surgery):
- Adequate bone marrow function: neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 10.0 g/dL
- Adequate liver function: Bilirubin \< 2.0 mg/dL, AST, ALT, AP, γ-GT \< 3 x ULN
- Adequate renal function: creatinine clearance \> =60 ml/min
- No distant metastases;
Exclusion
- Nasopharyngeal carcinoma;
- R2 resection;
- Invalid informed consent;
- Performance Status \> 1;
- Previous chemotherapy or radiotherapy for carcinoma of the head and neck;
- Prior exposure to EGFR pathway targeting therapy;
- Other serious illness or medical conditions:
- Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4;
- Clinically significantly abnormal electrocardiogram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal
- Significant neurologic or psychiatric disorders including dementia or seizures;
- Active uncontrolled infection;
- Active disseminated intravascular coagulation;
- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
- Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass;
- Having participated in another therapeutic clinical trial or any investigational agent in the preceding 30 days;
- Known allergic/hypersensitivity reaction to any of the components of the treatment;
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding;
- Known drug abuse;
- Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;
- Legal incapacity or limited legal capacity;
- Sensitivity and incompatibility against 5-Fluorouracil
- Sensitivity and incompatibility against platinum-compounds
- Known incompatibilities \>grade 3 towards cetuximab
- expected incompliance of patient (e.g. in case of severe alcohol addiction)
- Dental evaluation: Pre treatment dental care before start of radiochemotherapy (approximately 8 to 10 days lapse-time is needed for complete recovery before initiation of radiation therapy).
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00791141
Start Date
August 1 2008
End Date
September 1 2013
Last Update
January 23 2014
Active Locations (10)
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1
Department of Radiotherapeutics of the University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
Department of Radiological Oncology University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
Department of Radiotherapy and Radiological Oncology University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
4
Department of Radiotherapy and Radiological Oncology University Hospital Ulm
Ulm, Baden-Wurttemberg, Germany, 89091