Patients with well differentiated neuroendocrine neoplasia (NENs) not eligible for active antitumoral treatments due to their clinical conditions. MedDRA version: 20.0 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: TEMOZOLOMIDE SUN - 20MG - CAPSULA RIGIDA - USO ORALE - BLISTER (ALU/ALU) 5X1 CAPSULE (DOSE UNITARIA)
Product Name: Temozolomide
Product Code: [Temozolomide]
Pharmaceutical Form: Capsule, h
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age > 18 years; • Histologically proven diagnosis of low grade GEP-NENs (in accordance with WHO 2019 classification), bronchial carcinoids (in accordance with the Travis classification), low grade of unknown primary sites NENs; • Advanced disease (unresectable locally advanced or metastatic); • ECOG performance status 2 and/or moderate medullary impairment (Hb concentration 3 prior systemic antitumor therapies (apart from SSA); • Functioning/non functioning; • Morphological progressive disease (CT scan or MRI); • Clinical progression (as judged by the investigator). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: • Patients pretreated with Temozolomide • Are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 28 days 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential; WOCBP childbearing potential who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol • Patients that did not sign written informed consent prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law • Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival (PFS).;Secondary Objective: • Objective response rate (ORR) that means complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs. • Duration of response. • Overall survival (OS). • Safety. • Quality of life (QoL) • Centralized evaluation of O6-methylguanine-DNA-methyltransferase (MGMT) status in tumor tissue to correlate clinical outcomes and MGMT status and validate the method of MGMT determination.;Primary end point(s): • Progression free survival (PFS);Timepoint(s) of evaluation of this end point: Every month during treatment period, every 3 months for the first 1 year after the end of the treatment, and then every 6 months for 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate (ORR) that means complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs. • Duration of response. • Overall survival (OS). • Safety. • Quality of life (QoL) • Centralized evaluation of O6-methylguanine-DNA-methyltransferase (MGMT) status in tumor tissue to correlate clinical outcomes and MGMT status and validate the method of MGMT determination;Timepoint(s) of evaluation of this end point: Every month during treatment period, every 3 months for the first 1 year after the end of the treatment, and then every 6 months for 1 year. | — |
Countries
Italy
Contacts
Public ContactUfficio Studi Clinici e Attività Re
Istituto Europeo di Oncologia
Outcome results
None listed