GTX Chemoradiation for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByWilliam Sherman, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.

Eligibility Criteria

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.

Inclusion Criteria

I have not had chemotherapy or radiation therapy before.

My disease is advanced but hasn't spread far, confirmed by a scan.

My tumor cannot be surgically removed because it is too close to major blood vessels.

Participant Groups

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.

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

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Xeloda for: