Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer

Neck Cancer Clinical Trial

Official title:

Induction Immunochemotherapy in Stage III-IVa Cancer of Oropharynx, Hypopharynx and Larynx

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05551767
• Other study ID #: HN01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 30, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2022
• Source: City Clinical Oncology Hospital No 1
• Contact: Ilya ? Pokataev
• Phone: +79262858986
• Email: pokia[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Neck Cancer

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Russian Federation	City clinical oncology hospital 1	Moscow
Russian Federation	Moscow City Oncology Hospital No 62	Moscow
Russian Federation	Moscow Clinical Scientific Center named after Loginov	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
City Clinical Oncology Hospital No 1	Moscow City Oncology Hospital No. 62, Moscow Clinical Scientific Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	progression-free survival	Time from start of treatment to radiological disease progression	through study completion, an average of 3 years
Secondary	overall survival	Time from start of treatment to death from any case	through study completion, an average of 3 years
Secondary	objective response rate	response rate by RESCIST 1.1	through study completion, an average of 3 years
Secondary	Organ-preserving treatment rate	rate of patients with organ sparing treatment	through study completion, an average of 3 years