radiation therapy for Pancreatic Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pancreatic Adenocarcinoma+1 Moreradiation therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of chemotherapy drugs with or without radiation therapy before surgery to see if it is more effective in treating pancreatic cancer.

Eligible Conditions
  • Pancreatic Adenocarcinoma
  • Borderline Resectable Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 5 years

1 year
Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE
18 months
Overall Survival (OS) Rate
Overall survival (OS) rate
24 months
Incidence of adverse events assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 4 and the Patient-Reported Outcomes version of the CTCAE
Pathologic Complete Rate (pCR) Rate
Pathologic complete rate (pCR) rate
Residual Tumor (R)0 Resection Rate
Residual tumor (R)0 resection rate
Year 4
Event-free Survival
5 years
Event-free survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

mFOLFIRINOX + surgery + FOLFOX
1 of 2
mFOLFIRINOX + radiation + surgery + FOLFOX
1 of 2

Experimental Treatment

126 Total Participants · 2 Treatment Groups

Primary Treatment: radiation therapy · No Placebo Group · Phase 2

mFOLFIRINOX + surgery + FOLFOXExperimental Group · 3 Interventions: mFOLFIRINOX, surgery, FOLFOX · Intervention Types: Drug, Procedure, Drug
mFOLFIRINOX + radiation + surgery + FOLFOXExperimental Group · 4 Interventions: radiation therapy, mFOLFIRINOX, surgery, FOLFOX · Intervention Types: Radiation, Drug, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radiation therapy
1994
Completed Phase 3
~13030
surgery
2005
Completed Phase 4
~6970
FOLFOX
2009
Completed Phase 3
~3760

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Sky FoundationUNKNOWN
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,729 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
503 Previous Clinical Trials
215,518 Total Patients Enrolled
Matthew Katz, MD, FACSStudy ChairThe University of Texas MD Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have stage IV disease, which is radiographically resectable.
You have no uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days of registration.
You have a performance status of 0 or 1.
References