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Chemotherapy

FOLFIRINOX or gemcitabine/abraxane followed by SBRT Dose level 1 for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Sana Karam, MD
Research Sponsored by University of Colorado, Denver
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 5 years
Awards & highlights

Study Summary

This study is evaluating whether a dose escalation of stereotactic body radiotherapy (SBRT) can be delivered safely in patients with locally advanced pancreatic cancer (LAPC) who have received induction chemotherapy (FOLFIRINOX or gemcitabine and nab-paclitaxel

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Advance Directives
Secondary outcome measures
Local Control
Overall Survival
Progression Free Survival
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: FOLFIRINOX or gemcitabine/abraxane followed by SBRT Dose level 3Experimental Treatment2 Interventions
SBRT will be administered in 3 fractions, every other day, on an outpatient basis, following chemotherapy with either FOLFIRINOX or gemcitabine/abraxane. Dose level 3 - 11 Gy x 3 fractions.
Group II: FOLFIRINOX or gemcitabine/abraxane followed by SBRT Dose level 2Experimental Treatment2 Interventions
SBRT will be administered in 3 fractions, every other day, on an outpatient basis, following chemotherapy with either FOLFIRINOX or gemcitabine/abraxane. Dose level 2 -10 Gy x 3 fractions
Group III: FOLFIRINOX or gemcitabine/abraxane followed by SBRT Dose level 1Experimental Treatment2 Interventions
SBRT will be administered in 3 fractions, every other day, on an outpatient basis, following chemotherapy with either FOLFIRINOX or gemcitabine/abraxane. Dose level 1- 9 Gy x 3 fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
SBRT
2014
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,731 Previous Clinical Trials
2,144,583 Total Patients Enrolled
Sana Karam, MDPrincipal InvestigatorUniversity of Colorado, Denver

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
clinicaltrials.govStudy
A Dose Escalation Trial of SBRT After Induction Chemotherapy for Locally Advanced Pancreatic Cancer
2016. "A Dose Escalation Trial of SBRT After Induction Chemotherapy for Locally Advanced Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02873598.
~2 spots leftby Apr 2025
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