NCT05527782Active, not recruitingPhase 2
Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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)
Source: ClinicalTrials.gov · Last updated 24 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 31 Aug 2022
- Start date
- 1 May 2019
- Primary completion date
- Aug 2025
- Lead sponsor
- Hospital Universitario Doctor Peset
- Diseases
- Head and neck cancer
- NCT number
- NCT05527782
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 1 May 2019 to the primary completion date, Aug 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- contraindications for cisplatin administration: renal insufficiency (eGFR \< 55ml/min), hearing loss, peripheral neuropathy
Other
- patients with p16 positive oropharyngeal carcinoma cT0-T3 N2 M0 (stage II), unless extranodal tumor extension
- dysphagia G\>2 with no percutaneous gastrostomy
- the presence of distant metastasis (M1)
Who the study is looking for
- 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:
- CT scan or MRI of the neck and CT scan of the chest or
- FDG18 PET TC
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Comarcal Francesc De Borja Coordinator of this site? Confirm its status | Gandia | Spain | Unknown status |
| Hospital Universitario Doctor Peset Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Marina Baixa Coordinator of this site? Confirm its status | Villajoyosa | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.