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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

To determine the safety of neoadjuvant accelerated fraction standard dose radiotherapy to 50 Gy with concomitant capecitabine in patients with resectable and borderline resectable pancreas cancer.

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,244,996 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have any open vacancies for participants?

"According to clinicaltrials.gov, this particular medical trial is no longer enrolling participants - the research was initially posted on August 1st 2010 and last updated April 8th 2011. Despite that, there are still 1032 other studies actively seeking volunteers at present."

Answered by AI

To what conditions has Standard Dose Accelerated Fraction Radiotherapy been applied effectively?

"Standard Dose Accelerated Fraction Radiotherapy may be used to treat a range of malignant neoplasms, including pancreatic endocrine carcinoma and colorectal carcinoma."

Answered by AI

How many participants can be accepted into this clinical research?

"This clinical trial is not longer open for enrollment. Its initial post date was August 1st 2010 and it had its last update on April 8th 2011. However, if you are still looking to participate in a medical study, 698 studies related to malignant neoplasm of pancreas and 334 concerning Standard Dose Accelerated Fraction Radiotherapy are actively recruiting volunteers."

Answered by AI

Has the FDA approved Standard Dose Acclerated Fraction Radiotherapy?

"Considering that Standard Dose Accelerated Fraction Radiotherapy is in Phase 2 of its trials, there is some evidence for safety but no data confirming efficacy. Subsequently, our team gave this drug a score of 2 on the 1 to 3 scale."

Answered by AI

Can you provide any information on prior experiments regarding Standard Dose Acclerated Fraction Radiotherapy?

"Currently, 334 Standard Dose Acclerated Fraction Radiotherapy studies are in progress with 126 of them having entered Phase 3. In Westmead, New South Wales alone there are a multitude of trials occurring for this treatment; however, opportunities to participate exist at 12828 centres worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiotherapy With Chemotherapy as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer

2010. "Radiotherapy With Chemotherapy as Neoadjuvant Therapy of Resectable and Borderline Resectable Pancreas Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01333332.

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