Back to resultsInduction Immunochemotherapy in Stage III-IVa Head and Neck Cancer
Primary Purpose
Neck Cancer
Status
Recruiting
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Neck Cancer
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.
Sites / Locations
- Moscow Clinical Scientific Center named after LoginovRecruiting
- City clinical oncology hospital 1Recruiting
- Moscow City Oncology Hospital No 62Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm 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. 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.
Outcomes
Primary Outcome Measures
complete response rate
rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy
progression-free survival
Time from start of treatment to radiological disease progression
Secondary Outcome Measures
overall survival
Time from start of treatment to death from any case
objective response rate
response rate by RESCIST 1.1
Organ-preserving treatment rate
rate of patients with organ sparing treatment
Full Information
NCT ID
NCT05551767
First Posted
September 16, 2022
Last Updated
September 21, 2022
Sponsor
City Clinical Oncology Hospital No 1
Collaborators
Moscow City Oncology Hospital No. 62, Moscow Clinical Scientific Center
1. Study Identification
Unique Protocol Identification Number
NCT05551767
Brief Title
Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer
Official Title
Induction Immunochemotherapy in Stage III-IVa Cancer of Oropharynx, Hypopharynx and Larynx
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City Clinical Oncology Hospital No 1
Collaborators
Moscow City Oncology Hospital No. 62, Moscow Clinical Scientific Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm 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. 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.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
cisplatin and 5-FU
Intervention 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)
Primary Outcome Measure Information:
Title
complete response rate
Description
rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy
Time Frame
through study completion, an average of 3 years
Title
progression-free survival
Description
Time from start of treatment to radiological disease progression
Time Frame
through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
overall survival
Description
Time from start of treatment to death from any case
Time Frame
through study completion, an average of 3 years
Title
objective response rate
Description
response rate by RESCIST 1.1
Time Frame
through study completion, an average of 3 years
Title
Organ-preserving treatment rate
Description
rate of patients with organ sparing treatment
Time Frame
through study completion, an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilya А Pokataev
Phone
+79262858986
Email
pokia@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Olesya Stativko
Phone
+79061522724
Email
olesya_stativko@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vsevolod N Galkin, Professor
Organizational Affiliation
City Clinical Oncology Hospital No 1
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moscow Clinical Scientific Center named after Loginov
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludmila G Zhukova
Facility Name
City clinical oncology hospital 1
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilya A Pokataev
Phone
+79262858986
Email
pokia@mail.ru
Facility Name
Moscow City Oncology Hospital No 62
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniil L Stroyakovsky
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer
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