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Chemotherapy

Gemcitabine, radiation therapy, surgery for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Issam Makhoul, MD
Research Sponsored by University of Arkansas
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 an average of 6 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The purpose of this phase II clinical trial study is to assess the resection rate among subjects who have been initially diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma. This will be done by providing preoperative treatment that will include alternating cycles of chemotherapy and radiotherapy treatment. In addition, this clinical trial will assess the safety of preoperative chemotherapy with radiation therapy for subjects with unresectable or borderline resectable adenocarcinoma of the pancreatic head, assess margin-negative resection rates, disease-free survival, assess overall survival rates, and determine patterns of local and distant recurrence.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Margin-negative Resection Rate

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gemcitabine, radiation therapy, surgeryExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pancreaticoduodenectomy
2018
N/A
~6220
Radiation therapy
2013
Completed Phase 3
~2850
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
495 Previous Clinical Trials
150,254 Total Patients Enrolled
Issam Makhoul, MDPrincipal InvestigatorUniversity of Arkansas
7 Previous Clinical Trials
231 Total Patients Enrolled
~1 spots leftby Dec 2025
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