TPF-C-HIT investigates the combination of induction chemotherapy with TPF followed by radioimmunotherapy with cetuximab and IMRT plus carbon ion boost with regard to efficacy and toxicity of the combination regimen.
TPF-C-HIT is a prospective, monocentric phase II trial efficacy, as measured by control and survival rates, as well as toxicity (acute and late effects) of the combined treatment with TPF-induction followed by radioimmunotherapy with the EGFR-antibody cetuximab and carbon ion boost in locally advanced squamous cell carcinoma of the head and neck (SCCHN). As long-term local control remains a therapeutic challenge in advanced head and neck cancer, locoregional control was chosen as the primary endpoint. Secondary endpoints are survival rates (disease-free survival, PFS, OS), acute and late radiation effects as well as adverse events. For development of prognostic markers, proteomic and genomic analyses are also included in the secondary endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
patients receive induction chemotherapy with TPF for a maximum of 3 cycles followed by radioimmunotherapy with cetuximab as intensity-modulated radiotherapy (IMRT) plus carbon ion boost
Dept of Radiation Oncology, University of Heidelberg
Heidelberg, Germany
Local-Regional Control (LRC)
The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year
Time frame: 12 months
disease-free survival (DFS)
Time frame: 12 months
progression-free survival (PFS)
Time frame: 12 months
overall survival (OS)
Time frame: 12 months
acute radiation effects
Time frame: 6 weeks post completion of radiotherapy
late radiation effects
Time frame: 12 months
adverse events
includes any adverse events attributable to the combined treatment not otherwise specified
Time frame: 12 months
proteomic and genomic analyses
proteomic and genomic analyses designed to investigate changes during therapy, therefore analyses are carried out at 6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy
Time frame: 6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy
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