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CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas

NCT03387592 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-03-10

No results posted yet for this study

Summary

This is a randomized phase II non comparative study. Patients with metastatic Neuroendocrine Carcinomas (NEC) Grade 3, will be enrolled in the study and will be randomly assigned to receive FOLFIRI or CAPTEM as second line treatment. Disease control rate (DCR) and safety are primary objectives, secondary objectives are Disease control rate (OS), Progression Free Survival (PFS), quality of life and toxicity of subsequent line of therapy (after Progression Disease PD) with an observational purpose.

Conditions

  • Neuroendocrine Carcinoma

Interventions

DRUG

CPT-11

180 mg/m2

DRUG

Calcio levofolinate

200 mg/m2

DRUG

5-Fluorouracil

400 mg/m2 + 2400 mg/m2

DRUG

Capecitabine

1500 mg/m2

DRUG

Temozolomide

200 mg/m2

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Toni Ibrahim, MD · Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387592 on ClinicalTrials.gov