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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
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 belowSelect...
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:Select...
My cancer has spread to distant parts of my body, or I have another type of cancer or cancer spread in the abdomen.
Select...
I have not had any major surgery in the last 28 days.
Select...
I do not have severe health issues like heart problems, recent infections, major surgeries, or allergies to certain medications.
Select...
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
620 Previous Clinical Trials
1,172,551 Total Patients Enrolled
Beth Erickson, MDPrincipal Investigator - Froedtert & The Medical College of Wisconsin
Froedtert & The Medical College of Wisconsin
Medical College Of Wisconsin (Medical School)
Medical College Wi Affil Hosps, Inc (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using effective birth control methods.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.I have not had any major surgery in the last 28 days.I do not have severe health issues like heart problems, recent infections, major surgeries, or allergies to certain medications.My pancreatic cancer is advanced and cannot be removed with surgery.I may or may not have swollen lymph nodes.I have no cancer spread to distant parts of my body and meet all health requirements.I've had radiation in the same area where my current cancer is.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation therapy plus chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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