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Spots Global Cancer Trial Database for Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Inoperable Patients

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Trial Identification

Brief Title: Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Inoperable Patients

Official Title: Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors: Phase II Study of Chemotherapy, Photon and Heavy Ion Radiotherapy Integration for More Effective and Less Toxic Treatment in Inoperable Patients

Study ID: NCT02099188

Study Description

Brief Summary: Sinonasal tumors are rare diseases, as they account for the 0.2 % - 0.8 % of all tumors. For patients with inoperable tumors, the prognosis is poor and the current therapy is a combined-modality treatment that is both more effective and associated with less morbidity. This study proposes innovative integration of multiple modality of treatment modulated by histology, molecular profile and response to induction CT.

Detailed Description: So far, surgery followed by radiotherapy (RT) has been the usual approach for advanced disease. Technical improvements in surgical approaches have been reported, providing less invasive surgery with lower morbidity. However, there are cases of unresectable tumors where the needs of novel strategies is higher. New therapeutic strategies are needed to obtain more efficient treatment with less morbidity. Some studies explored the role and feasibility of induction chemotherapy (CT) and the prognostic value of response to CT. Histology and molecular pattern can guide the type of administered CT. The first drives the choice of drug to be associated with Cisplatin, while mutational status of p53 (wild type, WT vs mutated, MUT) is a predictive value for response to CT with Cisplatin plus 5-Fluorouracil and Leucovorin in ITAC. Moreover, proton/carbon ion beam therapy, compared to conventional photon therapy, provides a more accurate and intense dose to tumor area, with potentially higher control of disease. Treatment outcomes for unresectable paranasal sinus carcinoma are poor, and combined-modality treatment is needed to find out novel therapeutic strategies.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Presidio Ospedaliero Spedali Civili di Brescia, Brescia, BS, Italy

Fondazione IRCCS Istituto Nazionale Tumori, Milano, MI, Italy

IRCCS Policlinico San Matteo, Pavia, PV, Italy

A.O. Ospedale di Circolo e Fondazione Macchi, Varese, VA, Italy

Azienda Ospedaliera "Maggiore della Carità", Novara, , Italy

Contact Details

Name: Lisa Licitra, MD

Affiliation: Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

Role: STUDY_DIRECTOR

Name: Piero Nicolai, MD

Affiliation: Presidi Ospedalieri Spedali Civili di Brescia

Role: PRINCIPAL_INVESTIGATOR

Name: Paolo Castelnuovo, MD

Affiliation: A.O. Ospedale di Circolo e Fondazione Macchi

Role: PRINCIPAL_INVESTIGATOR

Name: Marco Benazzo, MD

Affiliation: IRCCS Policlinico San Matteo

Role: PRINCIPAL_INVESTIGATOR

Name: Letizia Deantonio, MD

Affiliation: Azienda Ospedaliera "Maggiore della Carità"

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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