Poor prognosis inoperable sinonasal tumors. MedDRA version: 15.1 Level: PT Classification code 10060768 Term: Nasal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: L01CD02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL TRIHYDRATE
CAS Number: 148408-66-6
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
Fondazione IRCCS Istituto Nazionale Tumori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed and dated IEC-approved Informed Consent. 2.Diagnosis of sinonasal tumor with the following histotypes: - Squamous Cell Carcinoma (SCC); - Sinonasal Undifferentiated Carcinoma (SNUC); - Small Cell Carcinoma Neuroendocrine Type (SmCCNET); - Pure Sinonasal Neuroendocrine Carcinoma (SNEC); - Intestinal Type Adenocarcinoma (ITAC) with a functional p53 gene; - Esthesioneuroblastoma with differentiation grade III-IV by Hyams 3.AJCC stage T4b. 4.Unresectable disease. 5.ECOG performance status 0-2. 6.Adequate bone marrow, renal and hepatic functionality, defined as haemoglobin >10 g/dL, neutrophils >1500/mmc, platelets > 100.000/mmc, creatinine value = 1.5 x ULN or calculated creatinine clearance (by Cockcroft and Gault’s formula) > 60 mL/min, transaminases values =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1.Previous radiotherapy or chemotherapy for head and neck district tumors (surgical treatment relapses are admitted). 2.Metastatic disease. 3.Cardiac, pulmonary, infective, neurological disease or any other medical condition that could interfere with treatment. 4.Unable and unwilling to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol. 5.Previous diagnosis of other malignant neoplasm in the last 3 years (in situ cervical cancer or completely excised basocellular/squamocellular skin cancer are always admitted). 6.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of the multimodality treatment in terms of progression-free survival (PFS) at 5 years, in patients with poor prognosis inoperable sinonasal tumors.;Secondary Objective: •To assess additional efficacy measure of the multimodality treatment in term of Overall Survival (OS) •To evaluate visual functionality preservation after multimodality treatment in term of visual preservation (function preservation). •To evaluate hearing function preservation. •To evaluate the safety of the multimodality treatment. •To assess the efficacy of the induction chemotherapy in term of Overall Response Rate (ORR) by RECIST criteria version 1.1. •To evaluate late toxicities related to radiotherapy (both photon radiotherapy [RT] and heavy ion RT) Exploratory objective: •To explore the prognostic/predictive value of biological markers;Primary end point(s): Progression Free Survival (PFS) at 5 years, defined as the time from enrollment to progression of disease or death for any cause.;Timepoint(s) of evaluation of this end point: At 5 years, at progression or at patient's death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Overall Survival (OS) defined as the time from enrollment (ITT population ) or treatment start ( PP population) to the date of death for any cause. 2)Ocular function preservation by visual field tests. 3)Hearing preservation performed by audiogram test. 4)Overall safety profile of the whole treatment characterized by type, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03), timing and relationship to study therapy of adverse events and laboratory abnormalities collected. 5)Objective Response Rate (CR and PR by RECIST criteria version 1.1). 6)Adverse events (characterized by type, severity, timing) and laboratories abnormalities (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03), induced by radiotherapy (both photon RT and heavy ion RT). Exploratory endpoint: 1)Analysis of predictive/prognostic biomarkers.;Timepoint(s) of evaluation of this end point: 1)At patient's death or at last follow up visit. 2 e 3)At pre-treatment and during follow up, until 8 years' follow up. 4, 5 e 6)All study period including follow up. | — |
Countries
Italy
Contacts
Public ContactPaolo Bossi
Fondazione IRCCS Istituto Nazionale Tumori
Outcome results
None listed