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

Phase 2

Active, not recruiting

• Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: modified TPF; Other: Quality of life assessment (QoL)

• Registration Number: NCT05527782
• Lead Sponsor: Hospital Universitario Doctor Peset

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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
induction mTPF	Quality of life assessment (QoL)	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
induction mTPF	modified TPF	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

Primary Outcome Measures

Name	Time	Method
objective response rate (ORR)	12 weeks after radiotherapy termination	percentage of partial and complete response rates (RR)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hospital Marina Baixa; 🇪🇸 Villajoyosa, Alicante, Spain

Hospital Comarcal Francesc De Borja; 🇪🇸 Gandia, Valencia, Spain

Hospital Universitario Doctor Peset; 🇪🇸 Valencia, Spain