A randomized phase II trial of captem or folfiri as SEcond-line therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET imaging and biological markers (SENECA study)

A randomized phase II trial of captem or folfiri as SEcond-line therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET imaging and biological markers (SENECA study) - SENECA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000767-17-IT

Enrollment

112

Registered

2018-09-19

Start date

2017-01-18

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Carcinomas 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)

Interventions

Trade Name: TEMOZOLOMIDE SUN - 100 MG - CAPSULE RIGIDE - USO ORALE - FLACONI(VETRO) 5 CAPSULE Product Name: TEMOZOLOMIDE_IRSTIRCCS Product Code: TEMOZOLOMIDE_IRSTIRCCS Pharmaceutical Form: Capsule, ha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histopathologic diagnosis of neuroendocrine carcinomas (GEP NEC and lung NEC), G3 with ki67 > 20%. 2. Male or Female, aged >=18 years. 3. Measurable disease according to RECIST 1.1 criteria. 4. Patients already received a first line treatment for metastatic disease with platinum compound–based regimen chemotherapy (Cisplatin/Carboplatin and etoposide; folfox4 or capox). 5. Life expectancy greater than 3 months 6. ECOG performance status = 2 Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: 1. Ki672.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess DCR and the safety as co-primary objective;Secondary Objective: The secondary objectives are: OS, PFS and quality of life. The secondary exploratory objectives are the assessment of the impact of PET with gallium on PFS and the evaluation of biomarkers. ;Primary end point(s): The primary endpoint of this trial is to assess the Disease Control Rate (DCR). Safety will be considered as co-primary.;Timepoint(s) of evaluation of this end point: 48 months	—

Measure

Time frame

Main Objective: The primary objective is to assess DCR and the safety as co-primary objective;Secondary Objective: The secondary objectives are: OS, PFS and quality of life. The secondary exploratory objectives are the assessment of the impact of PET with gallium on PFS and the evaluation of biomarkers. ;Primary end point(s): The primary endpoint of this trial is to assess the Disease Control Rate (DCR). Safety will be considered as co-primary.;Timepoint(s) of evaluation of this end point: 48 months

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of tissue and circulating biomarkers as prognostic and predictive factors ;Timepoint(s) of evaluation of this end point: 48 months	—

Countries

Italy

Contacts

Public ContactCentro di Coordinamento Studi IRST

IRST IRCCS

cc.ubsc@irst.emr.it0544285813

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026