Unresectable Sinonasal Tumors Clinical Trial
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
| Verified date | April 2022 |
| Source | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 27 |
| Est. completion date | January 2024 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 < 1.5 times over the upper limit of normal (ULN). 7. Polychemotherapy treatment clinical feasibility as per Investigator's Judgment. 8. Male or female patients = 18 years of age. 9. Negative pregnancy test (if female in reproductive years). 10. Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation, if men and women of child producing potential. 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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Presidio Ospedaliero Spedali Civili di Brescia | Brescia | BS |
| Italy | Fondazione IRCCS Istituto Nazionale Tumori | Milano | MI |
| Italy | Azienda Ospedaliera "Maggiore della Carità" | Novara | |
| Italy | IRCCS Policlinico San Matteo | Pavia | PV |
| Italy | A.O. Ospedale di Circolo e Fondazione Macchi | Varese | VA |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Regione Lombardia |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Progression Free Survival (PFS) at 5 years, defined as the time from enrollment to progression of disease or death for any cause; last date of follow up will be registered for patients alive not in progression. | PFS will be assessed at 5 years. | |
| Secondary | Overall survival (OS) | Overall survival defined as the time from enrollment (ITT population) or treatment start (PP population) to the date of death from any causes; last date of follow up will be registered for patients alive. | Overall survival will be assessed at the following time frames: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months. | |
| Secondary | Ocular function preservation by visual field tests. | Ocular function preservation by visual field tests. | At the enrollment. During follow-up after: 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months. | |
| Secondary | Hearing preservation performed by audiogram test. | Hearing preservation performed by audiogram test. | At the enrollment. During follow-up after: 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months. | |
| Secondary | Overall safety profile of the whole treatment. | 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. | From the day of the Informed Consent Form signature through to 90 days after the last dose of the last therapy administered (i.e., radiotherapy and/or chemotherapy). | |
| Secondary | Objective Response Rate | Objective Response Rate (CR and PR by RECIST criteria version 1.1) | After the end of 1st, 3rd and 5th cycle of induction therapy and before the radiotherapy. During f-up at the following time frames: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, 60 months. | |
| Secondary | Adverse events and laboratories abnormalities. | 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). | During the treatments. F-up at the following time frames: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months. |