Pancreatic Cancer Research

Clinical trialPhase 2Terminated

FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Phase II Trial of FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Outcome
Stopped early. Results posted; no primary outcome with dataSlow accrual (Enrollment)
Phase
Phase 2
Status
Terminated
Study type
Interventional
Start
1 February 2017
Ended
7 September 2018
Enrollment
2 participants
Sites
1
Primary outcomes
Objective Radiographic Response Rate (ORR)
Sponsor type
Academic / other
Results posted
11 December 2018
Last update
27 November 2020

These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.

Results

Primary endpoint
Results posted; no primary outcome with dataAs posted on ClinicalTrials.gov ↗, registry record of 27 November 2020
Primary outcome, no data
Objective Radiographic Response Rate (ORR)The registry’s note: Due to low accrual, study was halted prematurely. No data, as no patients were analyzed.
Participants
FOLFIRINOX Treatment: 2 started, 2 completed
Serious adverse events
FOLFIRINOX Treatment: 0 of 2Participants with at least one serious adverse event, of those at risk, as posted

Every value is copied from the trial’s results record at ClinicalTrials.gov. “Statistically significant” describes the posted test only: it does not say which group did better, and nothing here is read from a paper.

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Source text

Brief summary public domain (ClinicalTrials.gov)

The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with gastroenteropancreatic high-grade neuroendocrine carcinomas. This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus beyond first-line).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Radiographic Response Rate (ORR) [Up to 36 months].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) [Up to 36 months].