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| Name | Class |
|---|---|
| Moscow City Oncology Hospital No. 62 | OTHER_GOV |
| Moscow Clinical Scientific Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy | through study completion, an average of 3 years |
| progression-free survival | Time from start of treatment to radiological disease progression | through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Time from start of treatment to death from any case | through study completion, an average of 3 years |
| objective response rate | response rate by RESCIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilya А Pokataev | Contact | +79262858986 | pokia@mail.ru | |
| Olesya Stativko | Contact | +79061522724 | olesya_stativko@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Vsevolod N Galkin, Professor | City Clinical Oncology Hospital No 1 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Clinical Scientific Center named after Loginov | Recruiting | Moscow | 111123 | Russia |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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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.
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|
| through study completion, an average of 3 years |
| Organ-preserving treatment rate | rate of patients with organ sparing treatment | through study completion, an average of 3 years |
| City clinical oncology hospital 1 | Recruiting | Moscow | 129090 | Russia |
|
| Moscow City Oncology Hospital No 62 | Recruiting | Moscow | 143423 | Russia |
|
| D014498 |
| Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |