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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
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
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 belowSelect...
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:Select...
I have not been diagnosed with any cancer except skin cancer in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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
782 Previous Clinical Trials
1,315,667 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pancreatic cancer is confirmed and not mainly neuroendocrine but may have mixed features.I am on warfarin and can have my INR checked weekly.I have not been diagnosed with any cancer except skin cancer in the last 5 years.My blood, liver, and kidney functions are within the required ranges.I am taking phenytoin and can have my levels checked weekly.I have a health condition that may shorten my life to under 6 months.I have not had any treatment for pancreatic cancer.I am 18 years old or older.My cancer is considered operable or nearly operable by a team of doctors.
Research Study Groups:
This trial has the following groups:- Group 1: Capecitabine, Radiation
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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