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Brief Title: Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Operable Patients
Official Title: Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors: Phase II Study of Chemotherapy, Surgery, Photon and Heavy Ion Radiotherapy Integration for More Effective and Less Toxic Treatment in Operable Patients
Study ID: NCT02099175
Brief Summary: Sinonasal tumors are rare diseases, so no standard treatment for such aggressive tumors has been reported, given rarity, absence of prospective study and heterogeneity of histologies and stages of diseases. This study proposes innovative integration of multiple modality of treatment depending by histology, molecular profile and response to induction CT. Moreover, such strategies allows the use of latest technology with greater biological effectiveness and reduction of toxicities.
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. In this scenario, multimodality treatment seems the best approach, even if there is lack of prospective data. 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. In addition, heavy ion therapy may produce less toxic side effects in a particularly critical area exposed to late RT toxicities and potentially can help in organ preservation strategies when exenteratio orbitae is requested.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Lisa Licitra, MD
Affiliation: Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
Role: STUDY_DIRECTOR
Name: Piero Nicolai, MD
Affiliation: Presidio Ospedaliero Spedali Civili di Brescia
Role: PRINCIPAL_INVESTIGATOR
Name: Paolo Calstelnuovo, 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: Andrea Sponghini, MD
Affiliation: Azienda Ospedaliera "Maggiore della Carità"
Role: PRINCIPAL_INVESTIGATOR