Poor prognosis sinonasal tumors in operable patients. 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
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. The inclusion of the maxillary sinus carcinomas is reserved only in cases requiring exenteratio orbitae for a radical surgery. 3.AJCC stage II-III-IVa with the exception of Esthesioneuroblastoma and Intestinal Type Ethmoid Adenocarcinoma where stage III-IV only will be included. 4.Resectable 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 20
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 operable 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 ocular preservation (organ preservation) in case surgical approach at diagnosis should consist of exenteratio orbitae and 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 correlate radiological response after induction chemotherapy (by RECIST criteria version 1.1) and pathological response in patients undergoing surgery. •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 five years, at progression or 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.Organ preservation and 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.Radiological response as per RECIST criteria (version 1.1) after last cycle of induction CT; pathological response defined as obtaining or not a pathologic complete response (i.e., absence of any residual viable tumor cell). 7.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. Analysis of predictive/prognostic biomarkers. ;Timepoint(s) of evaluation of this end point: 1. At patient's death or at last follw up visit. 2, 3. At pretreatment and during follow up until 8 years' follow up 4, 5, 6, 7. All study period including follow up | — |
Countries
Italy
Contacts
Public ContactPaolo Bossi
Fondazione IRCCS Istituto Nazionale Tumori
Outcome results
None listed