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Radiation Therapy

MR-Guided Radiation + Chemotherapy for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Beth Erickson, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically confirmed (histologic or cytologic), locally advanced, adenocarcinoma of the pancreas; patients must have unresectable disease based on institutional standardized criteria of unresectability or medical inoperability

Be older than 18 years old

Must not have

Distant metastatic disease, second malignancy or peritoneal seeding

Any major surgery within 28 days prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people with pancreatic cancer who are ineligible for surgery. To be eligible, patients must have received several months of chemotherapy and their tumor must not have progressed on imaging studies.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin changes or irritation where the radiation is aimed, fatigue, nausea, vomiting, diarrhea from chemotherapy, and increased risk of infections due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have not had any major surgery in the last 28 days.

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I do not have severe health issues like heart problems, recent infections, major surgeries, or allergies to certain medications.

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I've had radiation in the same area where my current cancer is.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Efficacy of dose escalation

Progression Free Survival

Radiation induced toxicity

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 5Eligibility criteria met