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)

Phase 1

• Conditions: euroendocrine Carcinomas; MedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000767-17-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-19
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 112

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

1.Ki67< 20%.
2.Patients with metastatic NECs already treated with irinotecan regimen.
3.Patients with a known hypersensitivity to fluorouracil or calcio levofolinato or Irinotecan or their recipients.
4.All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE).
5.Life expectancy minor than 3 months.
6.ECOG performance status >2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>The secondary exploratory objectives are the assessment of the impact of PET with gallium on PFS and the evaluation of biomarkers. <br>;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 Outcome Measures

Name	Time	Method
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