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

April 22, 2025 updated by: Sebastian Ochenduszko, Hospital Universitario Doctor Peset

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)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46017
        • Hospital Universitario Doctor Peset
    • Alicante
      • Villajoyosa, Alicante, Spain, 03570
        • Hospital Marina Baixa
    • Valencia
      • Gandia, Valencia, Spain, 46702
        • Hospital Comarcal Francesc De Borja

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: induction mTPF
  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
Drug: modified TPF
modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapy
Other: Quality of life assessment (QoL)
Quality of life assessment with questionnaires: EORTC QLQ-C30 and QLQ H&N-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: 12 weeks after radiotherapy termination
percentage of partial and complete response rates (RR)
12 weeks after radiotherapy termination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 month progression free survival (PFS)
Time Frame: 2 years
PFS at 24 months after treatment initiation
2 years
24 month overall survival (OS)
Time Frame: 2 years
OS at 24 months after treatment initiation
2 years
toxicity of induction mTPF
Time Frame: up to 10 weeks
percentages of patients with adverse effects during induction mTPF
up to 10 weeks
toxicity of concurrent chemoradiotherapy (CCRT)
Time Frame: through study completion, an average of 2 years
percentages of patients with adverse effects during CCRT
through study completion, an average of 2 years
EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Time Frame: 9 months
measurement of patients' physical, psychological and social functions
9 months
EORTC Head and Neck Cancer specific module (EORTC QLQ-H&N35)
Time Frame: 9 months
assessment the HR-QoL specific for head-and-neck cancer patients
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment compliance according to the protocol
Time Frame: 2 years
percentage of patients that have completed the sequence of induction mTPF followed by CCRT
2 years
treatment dose modifications and delays
Time Frame: 2 years
percentage of patients that have required dose reductions and/or delays in the administration of induction mTPF
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Doctor Peset

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUDP-CyC-01/2022

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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