Neck Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPembrolizumab
3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg)
Sponsors
Moscow City Oncology Hospital No. 62
Moscow Clinical Scientific Center
City Clinical Oncology Hospital No 1
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Squamous cell cancer of oropharynx (p16+: T0-3N3, T4N0-3, p16- : T3-4aN0-1, T1-4aN2-3), hypopharynx (T2-3N0-3, T1N+, T4aN0-3) or larynx III-IVa (T1-2N2-3, T3N2-3, T4aN0-3) , TNM8 staging classification; * Tumor is morphlogically confirmed; * CPS\>1 (22C3 clone); * ECOG 0-2; * Age above 18 years; * Signed Informed consent form.
Exclusion criteria
* Cancer of nasopharynx; * Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer; * Stages I or II; * ECOG\>=3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response rate | through study completion, an average of 3 years | rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy |
| progression-free survival | through study completion, an average of 3 years | Time from start of treatment to radiological disease progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | through study completion, an average of 3 years | Time from start of treatment to death from any case |
| objective response rate | through study completion, an average of 3 years | response rate by RESCIST 1.1 |
| Organ-preserving treatment rate | through study completion, an average of 3 years | rate of patients with organ sparing treatment |
Countries
Russia
Contacts
Primary ContactIlya А Pokataev
Backup ContactOlesya Stativko
Outcome results
None listed