A Phase 2 interventional study of modified TPF and Quality of life assessment (QoL) in Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by Hospital Universitario Doctor Peset. Active, not recruiting at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Hospital Universitario Doctor Peset · Phase 2, Interventional, and Treatment
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
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Hospital Universitario Doctor Peset is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
initial clinical staging evaluated in:
Exclusion Criteria:
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 · Other: Quality of life assessment (QoL)
modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapy
Quality of life assessment with questionnaires: EORTC QLQ-C30 and QLQ H\&N-35
objective response rate (ORR)
percentage of partial and complete response rates (RR)
Time frame: 12 weeks after radiotherapy termination
24 month progression free survival (PFS)
PFS at 24 months after treatment initiation
Time frame: 2 years
24 month overall survival (OS)
OS at 24 months after treatment initiation
Time frame: 2 years
toxicity of induction mTPF
percentages of patients with adverse effects during induction mTPF
Time frame: up to 10 weeks
toxicity of concurrent chemoradiotherapy (CCRT)
percentages of patients with adverse effects during CCRT
Time frame: through study completion, an average of 2 years
EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
measurement of patients' physical, psychological and social functions
Time frame: 9 months
EORTC Head and Neck Cancer specific module (EORTC QLQ-H&N35)
assessment the HR-QoL specific for head-and-neck cancer patients
Time frame: 9 months
treatment compliance according to the protocol
percentage of patients that have completed the sequence of induction mTPF followed by CCRT
Time frame: 2 years
treatment dose modifications and delays
percentage of patients that have required dose reductions and/or delays in the administration of induction mTPF
Time frame: 2 years
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Doctor Peset