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Clinical Trials in Spain / NCT05527782
Active, not recruiting Phase 2

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

NCT05527782 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitario Doctor Peset
Phase
Phase 2
Started
2019-05-01
Last updated
2025-04-24

Condition(s) studied

Locally Advanced Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

modified TPFQuality of life assessment (QoL)

modified TPF: modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapy

Quality of life assessment (QoL): Quality of life assessment with questionnaires: EORTC QLQ-C30 and QLQ H\&N-35

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN): oral cavity, oropharynx, larynx, hypopharynx, and unknown primary * 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)

Primary outcome measure(s)

  • objective response rate (ORR) — 12 weeks after radiotherapy termination
    percentage of partial and complete response rates (RR)

Trial sites (3)

FacilityCityRegionStatus
Hospital Marina Baixa Villajoyosa Alicante
Hospital Comarcal Francesc De Borja Gandia Valencia
Hospital Universitario Doctor Peset Valencia Spain

Other trials for the same condition

CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation) Recruiting
A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05527782 on ClinicalTrials.gov ↗ ← All trials in Spain