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Anti-metabolites

Fluorouracil for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Davendra Sohal
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years for the estimates of median overall survival. up to 2 years for statistical analysis 1 and 2, comparing the observed 2-year overall survival (os) to the null hypothesis of 40%, in each arm.
Awards & highlights

Study Summary

This trial is studying how well a combination of fluorouracil, irinotecan hydrochloride, and oxaliplatin works compared to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years for the estimates of median overall survival. up to 2 years for statistical analysis 1 and 2, comparing the observed 2-year overall survival (os) to the null hypothesis of 40%, in each arm.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for the estimates of median overall survival. up to 2 years for statistical analysis 1 and 2, comparing the observed 2-year overall survival (os) to the null hypothesis of 40%, in each arm. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Disease-free Survival From the Time of R0 or R1 Resection.
Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection.
Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection.
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (gemcitabine, nab-paclitaxel, and surgery)Experimental Treatment3 Interventions
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (mFOLFIRINOX, surgery)Experimental Treatment4 Interventions
Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Oxaliplatin
2011
Completed Phase 4
~2560
Pancreatectomy
2012
Completed Phase 2
~160
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
2007
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,664 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,006 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,023 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Annals of SurgeryJournal
Surgical Outcome Results from SWOG S1505
Ahmad, Syed A., Mai Duong, Davendra P. S. Sohal, Namita S. Gandhi, Muhammad Shaalan Beg, Andrea Wang-Gillam, James L. Wade, et al.. 2020. “Surgical Outcome Results from SWOG S1505”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0000000000004155.
JAMA OncologyJournal
Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma
Sohal, Davendra P. S., Mai Duong, Syed A. Ahmad, Namita S. Gandhi, M. Shaalan Beg, Andrea Wang-Gillam, James L. Wade III, et al.. 2021. “Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2020.7328.
JAMA OncologyJournal
Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma
Sohal, Davendra P. S., Mai Duong, Syed A. Ahmad, Namita S. Gandhi, M. Shaalan Beg, Andrea Wang-Gillam, James L. Wade III, et al.. 2021. “Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2020.7328.
clinicaltrials.govStudy
S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
2016. "S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02562716.
~16 spots leftby Apr 2025
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