Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer
NCT ID: NCT05551767
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2022-08-30
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental arm
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.
Pembrolizumab
3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg)
Interventions
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Pembrolizumab
3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor is morphlogically confirmed;
* CPS\>1 (22C3 clone);
* ECOG 0-2;
* Age above 18 years;
* Signed Informed consent form.
Exclusion Criteria
* Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer;
* Stages I or II;
* ECOG\>=3.
18 Years
ALL
No
Sponsors
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Moscow City Oncology Hospital No. 62
OTHER_GOV
Moscow Clinical Scientific Center
OTHER
City Clinical Oncology Hospital No 1
OTHER_GOV
Responsible Party
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Principal Investigators
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Vsevolod N Galkin, Professor
Role: PRINCIPAL_INVESTIGATOR
City Clinical Oncology Hospital No 1
Locations
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Moscow Clinical Scientific Center named after Loginov
Moscow, , Russia
City clinical oncology hospital 1
Moscow, , Russia
Moscow City Oncology Hospital No 62
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Ludmila G Zhukova
Role: primary
Daniil L Stroyakovsky
Role: primary
Other Identifiers
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HN01
Identifier Type: -
Identifier Source: org_study_id
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