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Trial Title:
Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
NCT ID:
NCT05527782
Condition:
Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
head and neck cancer
induction chemotherapy
modified TPF
concurrent chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
modified TPF
Description:
modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent
chemoradiotherapy
Arm group label:
induction mTPF
Intervention type:
Other
Intervention name:
Quality of life assessment (QoL)
Description:
Quality of life assessment with questionnaires: EORTC QLQ-C30 and QLQ H&N-35
Arm group label:
induction mTPF
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients with locally advanced squamous cell carcinoma of the head and neck
(LASCCHN): oral cavity, oropharynx, larynx and hypopharynx
- 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Marina Baixa
Address:
City:
Villajoyosa
Zip:
03570
Country:
Spain
Status:
Recruiting
Contact:
Last name:
María Asunción Algarra, MD
Phone:
+34 966 907 200
Email:
mariasun.algarra@gmail.com
Investigator:
Last name:
María Asunción Algarra, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Comarcal Francesc De Borja
Address:
City:
Gandia
Zip:
46702
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Benjamin Domingo Arrué, MD
Phone:
+34962 84 95 00
Email:
bdomingoarrue@gmail.com
Investigator:
Last name:
Benjamin Domingo Arrué, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Doctor Peset
Address:
City:
Valencia
Zip:
46017
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Sebastian Ochenduszko, MD, PhD
Phone:
0034 963189169
Email:
sebaochenduszko@gmail.com
Contact backup:
Last name:
Monica Tallon, MSc
Phone:
0034 963189169
Email:
oncopeset@gmail.com
Start date:
May 1, 2019
Completion date:
December 2024
Lead sponsor:
Agency:
Hospital Universitario Doctor Peset
Agency class:
Other
Source:
Hospital Universitario Doctor Peset
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527782
