NCT01839799

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-04-01
• Completion: 2017-07-01
• First posted: 2013-04-25
• Last updated: 2021-02-25
• Results posted: 2021-02-25

Locations

1 site across 1 country: United States