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Anti-metabolites

Radiotherapy + Capecitabine for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function: Hematologic (ANC ≥ 1.5 x 10^9 cells/liter, Plts ≥ 100,000 x 10^9 cells/liter), Hepatic (Total bilirubin ≤ 5 fold the upper limits of normal for laboratory if due to biliary obstruction secondary to disease, AST/ALT ≤ 5 fold the upper limits of normal for laboratory), Renal (Creatinine clearance as measured by Cockcroft-Gault of >30 mL/min).
No prior therapy for pancreatic cancer, including surgery, radiation, or chemotherapy.
Must not have
Other malignancy diagnosed within the past 5 years, excepting all in situ cancers and invasive nonmelanomatous skin cancers.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new way to give radiation and chemotherapy to patients with locally advanced pancreas cancer. They want to see if it is safe and if it shrinks the tumor.

Who is the study for?
This trial is for adults over 18 with resectable or borderline resectable pancreatic cancer, who haven't had prior treatments. They must be able to consent and follow study procedures, have no other cancers in the past 5 years (except certain skin cancers), and not be pregnant while using reliable contraception. Adequate organ function is required.
What is being tested?
The trial tests neoadjuvant therapy combining accelerated fraction radiotherapy with chemotherapy (Capecitabine) on patients with advanced pancreatic cancer. It aims to assess safety and how well tumors respond before surgical removal.
What are the potential side effects?
Potential side effects may include fatigue, skin reactions from radiation, gastrointestinal symptoms like nausea or diarrhea due to Capecitabine, blood count changes affecting immunity and clotting, liver enzyme alterations, and kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood, liver, and kidney functions are within the required ranges.
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I have not had any treatment for pancreatic cancer.
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I am 18 years old or older.
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My cancer is considered operable or nearly operable by a team of doctors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not been diagnosed with any cancer except skin cancer in the last 5 years.

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Capecitabine, RadiationExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,262 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01333332 — Phase 2
Pancreatic Cancer Research Study Groups: Capecitabine, Radiation
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01333332 — Phase 2
Pancreatic Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT01333332 — Phase 2
~2 spots leftby Sep 2025
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