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

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Trial Identification

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

Study Description

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.

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: 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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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