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PRRT + Surgery for Pancreatic Cancer
Phase 1 & 2
Recruiting
Led By Xavier Keutgen, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of combining PRRT with tumor removal surgery to treat pancreatic neuroendocrine tumors. It will last 2 yrs and could help improve treatment.
Who is the study for?
This trial is for adults over 18 with metastatic Pancreatic neuroendocrine tumors (PanNET) spread to the liver, who haven't had chemotherapy in the last 4 weeks. Candidates must have a certain level of tumor uptake on a PET CT scan and be aiming for significant surgical tumor removal. Exclusions include brain metastases, heart failure, uncontrolled diabetes, pregnancy, poor renal function, other cancers except specific types without recurrence.Check my eligibility
What is being tested?
Researchers are testing if combining Peptide Receptor Radionuclide Therapy (PRRT) using Lutathera with surgery to remove tumors from the liver is more effective than surgery alone in treating PanNETs. This study will last about two years and aims to assess safety and effectiveness of this combination therapy.See study design
What are the potential side effects?
Potential side effects may include those typical of radionuclide therapies such as nausea, vomiting, fatigue; kidney damage; blood cell count changes leading to increased infection risk or bleeding problems; and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Difference in imaging characteristics
Improvement in Overall Survival
Improvement in Progression-Free Survival (PFS2)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 (peptide receptor radionuclide therapy + cytoreductive surgery)Experimental Treatment3 Interventions
Arm 2 will undergo four cycles of peptide receptor radionuclide therapy (PRRT) before cytoreductive surgery.
Group II: Arm 1- Control Arm - Standard Of Care - no peptide receptor radionuclide therapyExperimental Treatment1 Intervention
Arm 1 is the control arm, which will undergo standard of care cytoreductive surgery (for the tumor). Participants in this arm will not receive peptide receptor radionuclide therapy (PRRT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cytoreductive surgery
2007
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,725 Total Patients Enrolled
Xavier Keutgen, MDPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.My cancer started in the pancreas and has spread to the liver.My brain metastases have been treated and are now stable.I have uncontrollable urine leakage that makes certain treatments unsafe.My tumor is a high-grade neuroendocrine tumor.I show signs of early liver failure or have cirrhosis or ascites.I am using effective non-hormonal contraception or am not of childbearing potential.I had liver therapy with Yttrium-90 over a year ago.My kidneys are not working well.My cancer is grade 1 or 2.I can have surgery to remove 90% or more of the cancer in my liver.My tumor shows SSTR2 expression on a special PET CT scan.I have no other cancers except for treated skin cancer or cervical carcinoma in situ.I've had radiation therapy to over 25% of my bone marrow.I do not have severe heart failure.My kidney function, measured by a specific test, is below a certain level.I haven't taken any systemic therapy or SSA for the last 4 weeks.I have been treated with Capecitabine or Temozolomide in the last year.More than half of my liver is affected by cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2 (peptide receptor radionuclide therapy + cytoreductive surgery)
- Group 2: Arm 1- Control Arm - Standard Of Care - no peptide receptor radionuclide therapy
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.
Is enrollment still available for this medical experiment?
"According to records on clinicaltrials.gov, this medical study is no longer active and has not been actively recruiting since November 8th 2022. Nevertheless, there are still 844 other trials seeking volunteers at the present moment."
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