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PRIMUS 001: A Study Looking at Two Different Chemotherapy Regimens in Patients With Metastatic Pancreatic Cancer

NCT04151277 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-02-08

No results posted yet for this study

Summary

This study is comparing two combinations of chemotherapy treatments in patients with metastatic pancreatic cancer. Half the participants will receive FOLFOX-A and the other half will receive AG. Treatment will continue until progression or patient/clinican decision or intolerable toxicity.

Conditions

  • Neoplasms Pancreatic

Interventions

DRUG

FOLFOX-A

Patients will recieve nab-paclitaxel, oxaliplatin, Folinic Acid and 5-FU in a 14 day cycle

DRUG

Gemcitabe and Abraxane

Patients will receive gemcitabine and nab-paclitaxel 3 weeks out of 4

DRUG

G-CSF

Patients in the FOLFOX-A arm will also receive daily G-CSF as primary prophylaxis for all cycles. This will be given as per local site policy for 14 day chemotherapy regimens

Sponsors & Collaborators

  • NHS Greater Glasgow and Clyde

    collaborator OTHER

  • University of Glasgow

    collaborator OTHER

  • Judith Dixon-Hughes

    lead OTHER

Principal Investigators

  • Janet Graham · NHS Greater Glasgow and Clyde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • United Kingdom

Study Locations

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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 NCT04151277 on ClinicalTrials.gov