Adenoid-cystic carcinoma MedDRA version: 12.1 Level: LLT Classification code 10001220 Term: Adenoid cystic carcinoma of the oral cavity
Conditions
Interventions
Trade Name: Erbitux 5mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
Current Sponsor code: EMD271786
Con
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically proven, or surgically resected adenoid-cystic carcinoma of the head and neck and •macroscopic or microscopic residual tumor (R1/ R2) or •Tumor stage >T3/T4 or •perineural invasion and •M0 stage •Written informed consent •Age between 18 and 70 years •Karnofsky Index = 70% •Adequate bone-marrow, liver, and kidney function: •neutrophils = 1.5 x 109/L, •thrombocytes = 100 x 109/L, •haemoglobin = 10.0 g/dL •bilirubin = 2.0 g/dL •SGOT, SGPT, AP, g-GT = 3 x ULN •serum creatinine = 1.5 mg/dL •Subject (male or female [=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Prior RT or chemotherapy for tumors of the head and neck •R0 resection •M1 (distant metastases) •prior immunotherapy •signs of active infection •other serious illnesses •Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias) •Significant neurologic or psychiatric disorders including dementia or seizures •Active disseminated intravascular coagulopathies •Other serious underlying medical conditions prohibiting the patient’s participation in the trial according to the judgement of the investigators •Active participation in another clinical trial within the past 30 days •Known allergic/ hypersensitivity reactions to non-human proteins •Women: pregnant (Positive serum/ urine ß-HCG ) or breast-feeding, •Known drug abuse, •Other previous malignancy within the past 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix, •Legal incapacity or limited legal capacity, •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to explore the toxicity of the combined modality regimen consisting of heavy ion therapy / IMRT and EGFR antibody immunotherapy, by assessing the rate of patients with mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4. ; Secondary Objective: Secondary endpoints include: • Local control rate (i.e. local relapse-free survival) • Distant control rate (i.e. distant relapse-free survival) • Overall disease-free survival • Overall survival • Toxicity according to NCI CTCAE V. 4 (especially mucositis, acneiform skin reactions, hypersensitivity reactions): frequency of occurrence by type and maximum grade; relationship with treatment; SAE ;Primary end point(s): Rate of patients with mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4. In order to comply with the statistical model chosen for the trial, the primary endpoint is re-formulated as a “feasibility rate”, i.e. the rate of patients without any grade 3 or 4 toxicity event (1 - toxicity rate). | — |
Countries
Germany
Outcome results
None listed