Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Operable Patients (NCT02099175) | Clinical Trial Compass
UnknownPhase 2
Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Operable Patients
Italy41 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated IEC-approved Informed Consent
. Diagnosis of sinonasal tumor with the following histotypes:
. AJCC stage II-III-IVa with the exception of Esthesioneuroblastoma and Intestinal Type Ethmoid Adenocarcinoma where stage III-IV only will be included.
. Resectable disease.
. ECOG performance status 0-2.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: PFS will be assessed at 5 years.
Trial details
NCT IDNCT02099175
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
. Polychemotherapy treatment clinical feasibility as per Investigator's Judgment.
. Male or female patients ≥ 18 years of age.
Exclusion criteria
. Previous radiotherapy or chemotherapy for head and neck district tumors (surgical treatment relapses are admitted).
. Metastatic disease.
. Cardiac, pulmonary, infective, neurological disease or any other medical condition that could interfere with treatment.
. Unable and unwilling to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol.
. 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).
. 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.
. Current or concomitant enrollment in another therapeutic clinical trial.