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A Health Service Research Study to Investigate Survival of Metastatic Pancreatic Cancer Patients After Sequential Chemotherapy

NCT03331640 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2022-01-11

No results posted yet for this study

Summary

The aim of the study is to assess the efficacy of second and third line therapies (OFF vs. FOLFIRI) in a sequential cross-over design in patients pretreated with nab-paclitaxel/gemcitabine first line.

Conditions

Interventions

DRUG

OFF

OFF: 5-FU 2000 mg/m2 as 24 hour infusion + Na folinic acid 200 mg/m2 on D1, 8, 15, 22 Oxaliplatin 85 mg/m2 on D8, 22 3 weeks rest after D22; Cycle q42d

DRUG

FOLFIRI Protocol

Irinotecan 180 mg /m2 5-FU 400 mg/m2 (bolus) + 2400 mg/m2 as 46 hour infusion Na folinic acid 200 mg/m2 Cycle q2w

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2021-09-13
Completion
2021-09-13

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03331640 on ClinicalTrials.gov