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Trial Title:
Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer
NCT ID:
NCT05551767
Condition:
Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Cisplatin
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab
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)
Arm group label:
Experimental arm
Other name:
cisplatin and 5-FU
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moscow Clinical Scientific Center named after Loginov
Address:
City:
Moscow
Zip:
111123
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ludmila G Zhukova
Facility:
Name:
City clinical oncology hospital 1
Address:
City:
Moscow
Zip:
129090
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ilya A Pokataev
Phone:
+79262858986
Email:
pokia@mail.ru
Facility:
Name:
Moscow City Oncology Hospital No 62
Address:
City:
Moscow
Zip:
143423
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Daniil L Stroyakovsky
Start date:
August 30, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
City Clinical Oncology Hospital No 1
Agency class:
Other
Collaborator:
Agency:
Moscow City Oncology Hospital No. 62
Agency class:
Other
Collaborator:
Agency:
Moscow Clinical Scientific Center
Agency class:
Other
Source:
City Clinical Oncology Hospital No 1
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05551767
