---
title: Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
nct_id: NCT05527782
overall_status: ACTIVE_NOT_RECRUITING
phase: PHASE2
sponsor: Hospital Universitario Doctor Peset
study_type: INTERVENTIONAL
primary_condition: Locally Advanced Head and Neck Squamous Cell Carcinoma
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05527782.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05527782"
ct_last_update_post_date: 2025-04-24
last_seen_at: "2026-05-12T06:10:39.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

**Official Title:** A Phase II Study of Efficacy and Safety of Induction Modified TPF (mTPF) Followed by Concurrent Chemoradiotherapy (CCRT) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LASCCHN)

**NCT ID:** [NCT05527782](https://clinicaltrials.gov/study/NCT05527782)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Hospital Universitario Doctor Peset
- **Conditions:** Locally Advanced Head and Neck Squamous Cell Carcinoma
- **Start Date:** 2019-05-01
- **Completion Date:** 2025-10
- **CT.gov Last Update:** 2025-04-24

## Brief 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

## Detailed Description

The prognosis of patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN) is poor, therefore continuous research effort is being made in order to improve treatment efficacy. Standard treatment consists of concurrent chemoradiotherapy (CCRT) with cisplatin. In spite of many clinical trials and meta-analyses, the improvement of patient outcomes with the use of induction chemotherapy (IC) hasn´t been clearly demonstrated, partially due to the high toxicity of the standard TPF (docetaxel+cisplatin+fluorouracil) regimen used most frequently in this setting. Therefore, the aim of this study is to evaluate the outcomes of patients with LASCCHN treated with a less toxic induction mTPF regimen followed by CCRT.

The study will include patients with LASCCHN who - by the decision of the multidisciplinary team - have been assigned treatment with IC followed by CCRT. After being informed about the study objectives and potential risks, all patients giving written informed consent and meeting all the eligibility criteria will start the treatment. According to the study protocol, participants will receive 4 cycles of induction mTPF regimen repeated every 2 weeks followed by computed tomography (CT) response evaluation. 3-6 weeks after having completed the last cycle of mTPF, patients without disease progression will start CCRT with 2 cycles of cisplatin every 3 weeks. Twelve weeks after radiotherapy termination, a PET-CT scan will be performed in order to evaluate the treatment outcome.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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)
```

## Arms

- **induction mTPF** (EXPERIMENTAL) — 1. 4 CYCLES OF INDUCTION mTPF: Docetaxel 40 mg/m2 iv day 1, Cisplatin 40 mg/m2 iv day 1, Leucovorin 400 mg/m2 iv followed by Fluorouracil (5FU) bolus 400 mg/m2 iv day 1, 5FU 1000 mg/m2 iv day 1-2, q2w. Primary neutropenic fever prophylaxis with GCSFs x 3 days
2. CONCURRENT CHEMORADIOTHERAPY WITH 2 CYCLES OF CISPLATIN 100mg/m2 iv q3w

## Interventions

- **modified TPF** (DRUG) — modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapy
- **Quality of life assessment (QoL)** (OTHER) — Quality of life assessment with questionnaires: EORTC QLQ-C30 and QLQ H\&N-35

## Primary Outcomes

- **objective response rate (ORR)** _(time frame: 12 weeks after radiotherapy termination)_ — percentage of partial and complete response rates (RR)

## Secondary Outcomes

- **24 month progression free survival (PFS)** _(time frame: 2 years)_
- **24 month overall survival (OS)** _(time frame: 2 years)_
- **toxicity of induction mTPF** _(time frame: up to 10 weeks)_
- **toxicity of concurrent chemoradiotherapy (CCRT)** _(time frame: through study completion, an average of 2 years)_
- **EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)** _(time frame: 9 months)_
- **EORTC Head and Neck Cancer specific module (EORTC QLQ-H&N35)** _(time frame: 9 months)_

## Locations (3)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital marina baixa|villajoyosa|alicante|spain` — added _(2026-05-12)_
- `locations.hospital comarcal francesc de borja|gandia|valencia|spain` — added _(2026-05-12)_
- `locations.hospital universitario doctor peset|valencia||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05527782.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05527782*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*