Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of induction mTPF chemotherapy followed by concurrent chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Doctor Peset

Criteria

Inclusion Criteria:

• patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN):

oral cavity, oropharynx, larynx and hypopharynx

• stage cT4 and/or cN2-N3, with no distant metastases (M0).

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2

• initial clinical staging evaluated in:

1. CT scan or MRI of the neck and CT scan of the chest or

2. FDG18 PET TC

Exclusion Criteria:

• patients with p16 positive oropharyngeal carcinoma cT0-T3 N2 M0 (stage II), unless extranodal tumor extension

• contraindications for cisplatin administration: renal insufficiency (eGFR < 55ml/min), hearing loss, peripheral neuropathy

• dysphagia G>2 with no percutaneous gastrostomy

• the presence of distant metastasis (M1)