Clinical trial NCT05527782: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Keywords: head and neck cancer
induction chemotherapy
modified TPF
concurrent chemoradiotherapy
Lead sponsor: Hospital Universitario Doctor Peset
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 criteria: 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 outcomes:
measure: objective response rate (ORR)
timeFrame: 12 weeks after radiotherapy termination
Secondary outcomes:
measure: 24 month progression free survival (PFS)
timeFrame: 2 years
measure: 24 month overall survival (OS)
timeFrame: 2 years
measure: toxicity of induction mTPF
timeFrame: up to 10 weeks
measure: toxicity of concurrent chemoradiotherapy (CCRT)
timeFrame: through study completion, an average of 2 years
measure: EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
timeFrame: 9 months
measure: EORTC Head and Neck Cancer specific module (EORTC QLQ-H&N35)
timeFrame: 9 months
Other outcomes:
measure: treatment compliance according to the protocol
timeFrame: 2 years
measure: treatment dose modifications and delays
timeFrame: 2 years
Locations:
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa
state: Alicante
city: Gandia
country: Spain
facility: Hospital Comarcal Francesc De Borja
state: Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
Study officials:
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