patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum, 5-FU and pembrolizumab followed by (chemo)radiation.
patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg)
Moscow Clinical Scientific Center named after Loginov
Moscow, Russia
RECRUITINGCity clinical oncology hospital 1
Moscow, Russia
RECRUITINGMoscow City Oncology Hospital No 62
Moscow, Russia
RECRUITINGcomplete response rate
rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy
Time frame: through study completion, an average of 3 years
progression-free survival
Time from start of treatment to radiological disease progression
Time frame: through study completion, an average of 3 years
overall survival
Time from start of treatment to death from any case
Time frame: through study completion, an average of 3 years
objective response rate
response rate by RESCIST 1.1
Time frame: through study completion, an average of 3 years
Organ-preserving treatment rate
rate of patients with organ sparing treatment
Time frame: through study completion, an average of 3 years
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