Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
head and neck cancer, induction chemotherapy, modified TPF, concurrent chemoradiotherapy
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.
Interventions
DRUGmodified TPF
modified TPF: modified docetaxel-cisplatin-fluorouracil followed by concurrent chemoradiotherapy
OTHERQuality of life assessment (QoL)
Quality of life assessment with questionnaires: EORTC QLQ-C30 and QLQ H&N-35
Sponsors
Hospital Universitario Doctor Peset
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 12 weeks after radiotherapy termination | percentage of partial and complete response rates (RR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) | 9 months | measurement of patients' physical, psychological and social functions |
| EORTC Head and Neck Cancer specific module (EORTC QLQ-H&N35) | 9 months | assessment the HR-QoL specific for head-and-neck cancer patients |
| toxicity of concurrent chemoradiotherapy (CCRT) | through study completion, an average of 2 years | percentages of patients with adverse effects during CCRT |
Other
| Measure | Time frame | Description |
|---|---|---|
| treatment compliance according to the protocol | 2 years | percentage of patients that have completed the sequence of induction mTPF followed by CCRT |
| treatment dose modifications and delays | 2 years | percentage of patients that have required dose reductions and/or delays in the administration of induction mTPF |
Countries
Spain
Outcome results
None listed