Clinical trial · Interventional
Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Inoperable Patients
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
NCT02099188CI-TRIAL-00064653unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Sinonasal Tumors | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Adriamycin | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Radiotherapy - Patients needing curative neck irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multimodality treatment
- description
- Squamocellular Carcinoma, Sinonasal Undifferentiated Carcinoma: * Docetaxel at 75 mg/m2 as IV infusion on Day 1 q3w * Cisplatin at 80 mg/m2 as IV infusion on Day 1 q3w * 5-fluorouracil at 800 mg/m2/day as IV infusion from Day 1 to Day 4 q3w Small cell carcinoma neuroendocrine type, Pure neuroendocrine carcinoma and grade III-IV Esthesioneuroblastoma. * Cisplatin at 33 mg/m2/day as IV infusion from Day 1 to Day 3 q3w. * Etoposide at 150 mg/m2/day as IV infusion from Day 1 to Day 3 q3w . Second cycle and every other cycle * Adriamycin at 20 mg/m2/day as IV infusion from Day 1 to Day 3 q3w. * Ifosfamide at 3000 mg/m2/day as IV infusion from Day 1 to Day 3 q3w. Intestinal Type Adenocarcinoma with functional p53. * Leucovorin\* at 250 mg/m2/day as IV infusion from Day 1 to Day 5 q3w. * Cisplatin at 100 mg/m2 as IV infusion on Day 2 q3w * 5-fluorouracil at 800 mg/m2/day as IV infusion from Day 2 to Day 5 q3w Followed by radiotherapy
- interventionNames
- Drug: Cisplatin
- Drug: Docetaxel
- Drug: 5-fluorouracil
- Drug: Etoposide
- Drug: Adriamycin
- Drug: Ifosfamide
- Drug: Leucovorin
- Radiation: Radiotherapy - Patients needing Elective Nodal Volume (ENI)
- Radiation: Radiotherapy - Patients not needing ENI
- Radiation: Radiotherapy - Patients needing curative neck irradiation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.