MedTrace Logo

A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

NCT01839799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-02-25

Study results available
· View outcomes & findings →

Summary

Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

Gemcitabine

1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15

DRUG

Abraxane

125 mg/m2 IV over 30 minutes, day 1, 8, 15

DRUG

FOLFIRINOX

Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated

RADIATION

Chemoradiation

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Peter O'Dwyer, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-04-30
Completion
2017-07-31

Countries

  • United States

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 NCT01839799 on ClinicalTrials.gov