MR-Guided Radiation + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByBeth Erickson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Medical College of Wisconsin

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This research study is for people who have pancreas cancer for which surgery is not recommended. Potential patients must have already received several months of chemotherapy before they are eligible for this study and there will not have been any detectable spread of their tumor on imaging studies following this chemotherapy course.

Eligibility Criteria

This trial is for adults with advanced pancreatic cancer that can't be removed by surgery. They should have completed at least 4 months of chemotherapy without the cancer spreading, as confirmed by imaging. Participants need to be able to swallow pills and use effective contraception if applicable.

Inclusion Criteria

I am using effective birth control methods.

My pancreatic cancer is advanced and cannot be removed with surgery.

I may or may not have swollen lymph nodes.

+1 more

Exclusion Criteria

Participation in another clinical treatment trial while on study

My cancer has spread to distant parts of my body, or I have another type of cancer or cancer spread in the abdomen.

I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.

+3 more

Participant Groups

The study tests a combination of dose-escalated radiation therapy guided by magnetic resonance (MR) imaging alongside concurrent chemotherapy drugs Gemcitabine and Capecitabine in patients who are not candidates for surgical treatment of their pancreatic cancer.

1Treatment groups

Experimental Treatment

Group I: Radiation therapy plus chemotherapyExperimental Treatment2 Interventions

MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine.