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Anti-metabolites

GTX Chemoradiation for Pancreatic Cancer

Phase 2 & 3
Waitlist Available
Led By William Sherman, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior chemotherapy or radiation therapy.
Locally advanced disease determined by Endoscopic ultrasound, CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial will study the safety and efficacy of a combination of Gemcitabine, Capecitabine, and Docetaxel in patients with locally advanced pancreatic cancer.

Who is the study for?
This trial is for patients with locally advanced pancreatic cancer that can't be removed by surgery due to blood vessel involvement. Participants must not have had prior chemotherapy or radiation, and should be ineligible for other priority studies. They need to understand the treatment process and consent willingly, without any medical conditions barring them from surgery or chemo.Check my eligibility
What is being tested?
The study tests a chemotherapy regimen called GTX (gemcitabine, capecitabine, docetaxel) over six cycles of three weeks each. Depending on blood vessel involvement (venous only or arterial), some may also receive radiotherapy. Successful treatment could lead to surgical removal of remaining cancer.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, low blood cell counts leading to increased infection risk, liver function changes, kidney stress indicated by abnormal BUN/creatinine levels, and potential tissue damage at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had chemotherapy or radiation therapy before.
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My disease is advanced but hasn't spread far, confirmed by a scan.
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My tumor cannot be surgically removed because it is too close to major blood vessels.

Timeline

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 effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate
Secondary outcome measures
To describe the effect of neoadjuvant GTX regimen on resectability for those with arterial involvement and those with venous involvement, separately

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group IIExperimental Treatment1 Intervention
Patients with arterial involvement and may have venous involvement with tumor treated with 6 cycles of GTX, thenb GX/RT and then surgery
Group II: Group IExperimental Treatment1 Intervention
Patients with only venous involvement Treated with 6 cycles og GTX and then surgery

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,426 Total Patients Enrolled
William Sherman, MDPrincipal InvestigatorColumbia University

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01065870 — Phase 2 & 3
Pancreatic Cancer Research Study Groups: Group I, Group II
Pancreatic Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT01065870 — Phase 2 & 3
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01065870 — Phase 2 & 3
~4 spots leftby Jul 2025
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