Study on Using MRI-Guided Radiation Therapy to Increase Radiation Dose for Unresectable Non-Metastatic Pancreatic Cancer
Sponsor: Medical College of Wisconsin
ClinicalTrials ID:NCT01972919
This clinical trial is for patients with pancreatic cancer that cannot be removed by surgery. Participants must have already completed several months of chemotherapy and show no signs of cancer spread on imaging tests to be eligible.
Patient Parameters
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Program Overview
The purpose of this study is to see if higher doses of radiation, guided by MRI, along with chemotherapy, can better control pancreatic cancer that cannot be surgically removed. Researchers want to find out if this approach is more effective than standard radiation doses used before or after surgery. The study will also look at the side effects of this higher dose radiation. Participants will receive two chemotherapy drugs: Capecitabine, taken orally twice a day on radiation days, and Gemcitabine, given by IV once a week during radiation. All participants will have already received chemotherapy before joining the study.
Description
This study is exploring whether using higher doses of radiation therapy, guided by MRI, can improve treatment outcomes for patients with pancreatic cancer that cannot be removed by surgery. The goal is to see if this approach can better control the cancer compared to standard radiation doses used in other settings. The study will also monitor any side effects from the higher radiation doses.
Participants will receive two chemotherapy drugs during the study: Capecitabine, which is taken as a pill twice a day on the same days as radiation therapy, and Gemcitabine, which is given through an IV once a week during radiation therapy. Before joining the study, all participants will have already completed a course of chemotherapy.
The study aims to deliver higher radiation doses while minimizing the risk of damage to nearby healthy organs. This is done by carefully targeting the radiation to the tumor using MRI guidance. Researchers will assess both immediate and long-term side effects of this treatment approach.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with locally advanced pancreatic cancer that cannot be removed by surgery.
- No signs of cancer spread to other parts of the body.
- Completed at least 4 months of chemotherapy before joining the study.
- Able to swallow pills.
- Age 18 or older.
- Good overall health with specific blood test results within normal ranges.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Men who are sexually active must agree to use contraception.
- Willing to provide informed consent and follow study procedures.
Exclusion Criteria
- Cancer has spread to other parts of the body or there is a second cancer.
- Previous radiation treatment to the same area that would overlap with the study treatment.
- Major surgery within 28 days before joining the study.
- Severe heart problems or recent heart attack.
- Active infections requiring IV antibiotics.
- Serious lung or digestive issues.
- Unable to undergo MRI scans.
- Pregnant or breastfeeding women.
- Allergic to study medications Capecitabine or Gemcitabine.
- Participating in another clinical trial.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Froedtert Hospital | 53226 | Milwaukee | Wisconsin |
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