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Chemotherapy
Chemotherapy + SBRT for Pancreatic Cancer
Phase 2
Recruiting
Led By Michael S. Rutenberg, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have been treated with systemic therapy with standard chemotherapy regimens (fluorouracil, irinotecan, leucovorin and oxaliplatin [FOLFIRINOX] or gemcitabine/nab-Paclitaxel or gemcitabine-doublet) with documented at least stable disease (by RECIST 1.1 imaging criteria), for at least 4 months prior to study enrollment
Image proven oligometastatic pancreatic cancer patients (i.e., synchronous & metachronous)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying the effect of combining standard chemotherapy with a new, more precise kind of radiation therapy to treat patients with pancreatic cancer that has spread to a limited number of places in the body.
Who is the study for?
This trial is for adults with a specific type of pancreatic cancer that has spread to a few other parts of the body. Participants must have had some success with standard chemotherapy, be in fairly good health, and not pregnant or breastfeeding. They should agree to use birth control and can provide tissue/blood samples.Check my eligibility
What is being tested?
The study compares standard chemotherapy alone versus combining it with precise radiation therapy (SBRT) for treating limited-spread pancreatic cancer. SBRT targets tumors accurately, aiming to improve outcomes and survival while minimizing damage to healthy tissues.See study design
What are the potential side effects?
Chemotherapy may cause nausea, fatigue, hair loss, increased risk of infection, and blood cell count changes. Stereotactic Body Radiation Therapy could lead to localized skin reactions, fatigue, and potential damage to nearby organs depending on the treatment area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been on chemo for my cancer and it hasn't gotten worse for at least 4 months.
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My pancreatic cancer has spread to a few other parts of my body.
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My cancer can be treated with SBRT, and I don't have positive peritoneal washings or Kras cfDNA.
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I am 18 years old or older.
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My pancreatic cancer diagnosis has been confirmed by Mayo Clinic's pathology department.
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My cancer cannot be measured with tests.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
Confirmed response rate
Incidence of adverse events
Overall survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (SBRT, chemotherapy)Experimental Treatment2 Interventions
Patients undergo SBRT QD or every other day for 5 fractions, and receive chemotherapy per standard of care.
Group II: Group II (chemotherapy)Active Control1 Intervention
Patients receive chemotherapy per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,952 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,767,103 Total Patients Enrolled
Michael S. Rutenberg, M.D., Ph.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to go back to the study site for follow-up visits.Your hemoglobin level, a measure of how much oxygen-carrying protein is in your blood, should be at least 9.0 grams per deciliter.I've been on chemo for my cancer and it hasn't gotten worse for at least 4 months.Your cancer can be measured using specific criteria called RECIST.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.Your white blood cell count is at least 1500 per cubic millimeter.Your blood platelet count is at least 100,000 per cubic millimeter.Your total bilirubin level in the blood needs to be within a certain range, unless you have a condition called Gilbert's syndrome, in which case it can be slightly higher.My blood clotting tests are normal or within the target range if I'm on blood thinners.My pancreatic cancer has spread to a few other parts of my body.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.Your liver enzymes (ALT and AST) levels should not be more than three times the normal limit, or five times the normal limit if you have liver involvement. This will be checked within 14 days before you join the study.I have had a heart attack in the last 6 months or have heart failure needing constant treatment.I have 5 or fewer tumors outside my brain.My cancer can be treated with SBRT, and I don't have positive peritoneal washings or Kras cfDNA.I am of childbearing age and not using birth control.I have not had any other cancer within the last year.I am currently breastfeeding.I have had radiation therapy in the same area before.I had surgery less than 3 weeks ago.I am 18 years old or older.My pancreatic cancer diagnosis has been confirmed by Mayo Clinic's pathology department.My cancer cannot be measured with tests.I am not taking any experimental drugs for my cancer.I am able to care for myself and perform daily activities.Your kidney function is good, with a certain level of waste removal from your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (SBRT, chemotherapy)
- Group 2: Group II (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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How secure is Stereotactic Body Radiation Therapy for human subjects?
"Stereotactic Body Radiation Therapy (SBRT) has been assessed by our team at Power and deemed a 2 on the safety scale. This is based off of Phase 2 trial results which indicate that SBRT is safe but further research needs to be done before efficacy can be confirmed."
Answered by AI
Are there any remaining vacancies in this trial for participants?
"As per the information provided on clinicaltrials.gov, this trial is not presently in search of candidates. It was initially posted on December 15th 2022 and amended for the last time on November 29th 2022. Although there are no current vacancies within this particular study, 1249 other trials are actively recruiting patients at present."
Answered by AI
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