Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Operable Patients

• Status: Active, not recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborator: Regione Lombardia
• Treatments: Cisplatin; Docetaxel; Doxorubicin; Etoposide; Etoposide phosphate; Fluorouracil; Ifosfamide; Isophosphamide mustard; Leucovorin; Liposomal doxorubicin

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 < 1.5 times over the upper normal limit (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.

7. Current or concomitant enrollment in another therapeutic clinical trial.