Multicenter, open-label phase II trial on post-surgery chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck with high risk of locoregional recurrence. - ACCRA-H
- Conditions
- This trial includes Patients with locally advanced squamous cell carcinoma of the head and neck (SCCH&N). In SCCH administration of chemotherapy of 5-FU and Cisplatin is a standard therapy. Herel the additional administration of cetuximab and radiotherapy under prior tumor resection is tested. Both therapies are each authorised therapies. The safety and efficacy of the combined therapies, especially on locregional recurrence of squamous cell carcinoma, will be evaluated.MedDRA version: 12.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck
- Registration Number
- EUCTR2007-002659-17-DE
- Lead Sponsor
- Heinrich-Heine-Universität Düsseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
-written informed consent
- Male or female patients between 18 and 70 years
-Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than maximum 9 weeks ago
-To be categorized as high risk, patients have to fulfil at least one of the following criterias: (R0 - resection <5 mm margin or R1 – resection or Extracapsular nodal extension)
-No previous chemotherapy and/or radiotherapy for carcinoma of the head and neck
-Performance status ECOG: 0 – 1
-Contraception in female partners of male patients and female patients with willingness to use effective contraceptive method for the study duration and 2 months post-dosing
-Adequate renal, liver and hematological functions within 9 weeks until surgery:
(-Adequate bone marrow function: neutrophils > 1.5 x 10e9/L, platelets > 100 x 10e9/L, hemoglobin > 10.0 g/dL;-Adequate liver function: Bilirubin < 2.0 mg/dL, AST, ALT, AP, ?-GT < 3 x ULN)
-Adequate renal function: creatinine clearance > 60 ml/min
- No distant metastases.
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
-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 or -Clinically significantly abnormal electrocardio-gram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal or-Significant neurologic or psychiatric disorders including dementia or seizures or-Active uncontrolled infection or -Active disse-minated intravascular coagulation or- 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 ß-HCG) or breast-feeding
-Known drug abuse of illeagal drugs
-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
- dental evaluation and pre treatment dental care before start of radiochemotherapy
- HIV infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method