Overview

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.