Pancreatic Neuroendocrine TumorPhase 1/2NCT05610826
Preoperative PRRT Versus Surgical Cytoreduction in Metastatic Pancreatic Neuroendocrine Tumors to the Liver
A Phase 1/2 study testing cytoreductive surgery, Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT) and Peptide receptor radionuclide therapy (PRRT) in people with Pancreatic Neuroendocrine Tumor and Pancreas Cancer, run by University of Chicago at 1 site in United States.
Trial summary
Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Tumor, Pancreas Cancer
- What is being tested?
- cytoreductive surgery, Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT) and Peptide receptor radionuclide therapy (PRRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 11 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic Pancreatic neuroendocrine tumors (PanNET) to the liver
- Well- or moderately differentiated (grade 1 or grade 2, Ki-
- Ability to aim for equal or greater than 90% hepatic cytoreduction surgically
- Proof of SSTR2 expression by uptake of tumor on 68Ga DOTATATE PET CT (Krenning Score on all or a majority of lesions
- Age older than 18 years
- No Somatostatin Analogues (SSA) or other systemic therapy for 4 weeks prior to starting PRRT, if randomized to arm 2.
Who cannot join
- Patient with G3 or poorly differentiated NET (grade 3, Ki-67 >20%)
- Previous liver-directed therapy with Yttrium-90 (TACE/TAE allowed if performed more than 12 months prior to enrollment)
- Systemic therapy with Capecitabine and/or Temozolamide within 12 months of enrollment.
- No tumor uptake on 68Ga DOTATATE PET CT
- Liver tumor burden > 50% (as defined by CT or MRI)
- Signs of early liver failure (T-Bilirubin >3, INR > 1.5, Albumin <3.0 g/dL unless prothrombin time is within the normal range) or cirrhosis or ascites
Show all 21Show fewer
- calculated by the Cockroft Gault method, eventually confirmed by measured creatinine clearance
- (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma
- camera-based) <50 mL/min (the measured creatinine clearance / GFR is required only as - confirmatory exam).
- 2. Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L - (75x103/mm3).
- Known brain metastases, unless these metastases have been treated and stabilized.
- Uncontrolled congestive heart failure (NYHA II, III, IV).
- Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
- Pregnancy or lactation.
- For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel). - Prior external beam radiation therapy to more than 25% of the bone marrow.
- Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP.
- Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.
- Patients who have not provided a signed informed consent form to accept this treatment.
- Poor renal function
- Quality Unit language added
- editorial changes
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
About this study
Official title: Preoperative PRRT Versus Surgical Cytoreduction Alone in Metastatic Pancreatic Neuroendocrine Tumors to the Liver: A Phase II Multi-institutional Trial
Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. PRRT itself is approved by the U.S. Food and Drug Administration (FDA) for people with PanNETs however the combination with cytoreduction is considered experimental.
Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
Read the detailed description
Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. PRRT itself is approved by the U.S. Food and Drug Administration (FDA) for people with PanNETs however the combination with cytoreduction is considered experimental.
Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
PRRT is a form of targeted treatment (think of a "lock and key") done by the use of a small molecule (Lutathera) Lutathera acts as a "key" to "lock" onto certain areas your tumor cells called receptors when injected into a vein and travels through the bloodstream. Lutetium-177 is the radionuclide in Lutathera which is a chemical that delivers strong radiation directly into your tumor cells and works by causing death of the cancerous tissues.
PRRT can only be done on patients who have tumors that have the somatostatin receptors. Before being given PRRT, your treating doctor will run imaging tests to make sure your tumors have these targeted receptors. Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
Participants will be randomized (like the flip of a coin) to one of two arms. Arm 1 is the control arm, which will undergo standard of care cytoreductive surgery (for the tumor). Arm 2 will undergo four cycles of PRRT before cytoreductive surgery.
- Conditions
- Pancreatic Neuroendocrine Tumor, Pancreas Cancer
- Being tested
- cytoreductive surgery, Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT), Peptide receptor radionuclide therapy (PRRT)
- Keywords
- pancreatic cancer, pancreas cancer
- Medical subject headings
- Adenoma, Islet Cell, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytoreductive surgeryProcedure or surgery
Cytoreductive surgery is an operation to remove as much tumor tissue as possible.
Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT)Drug
PRRT is a form of targeted treatment (think of a "lock and key") done by the use of a small molecule (Lutathera). Lutathera acts as a "key" to "lock" onto certain areas your tumor cells called receptors when injected into a vein and travels through blood.
Peptide receptor radionuclide therapy (PRRT)Procedure or surgery
PRRT is a molecular targeted therapy used to treat neuroendocrine tumors (NET). Molecular targeted therapies use drugs or other substances to identify and attack cancer cells while reducing harm to healthy tissue. PRRT delivers high doses of radiation to tumors in the body to destroy or slow their growth and reduce disease side effects.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Control Arm - Standard Of Care - no peptide receptor radionuclide therapy | Other | 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). Receives: Procedure: cytoreductive surgery |
| Arm 2 (peptide receptor radionuclide therapy + cytoreductive surgery) | Experimental | Arm 2 will undergo four cycles of peptide receptor radionuclide therapy (PRRT) before cytoreductive surgery. Receives: Procedure: cytoreductive surgery; Drug: Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT); Procedure: Peptide receptor radionuclide therapy (PRRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
To determine whether preoperative peptide receptor radionuclide therapy (PRRT) prior to hepatic cytoreduction increases progression free survival (PFS1) (when compared to cytoreduction alone) in patients with metastatic PanNETs to the liver
Measured: 2 years
Secondary outcomes (6)
Overall Survival
To determine whether preoperative peptide receptor radionuclide therapy (PRRT) prior to hepatic cytoreduction increases overall survival.
(when compared to cytoreduction alone) in patients with metastatic PanNETs to the liver
Measured: 2 years
Objective Response Rate
To determine whether preoperative peptide receptor radionuclide therapy (PRRT) induces a significant objective response rate (according to RECIST) in the primary tumor (if available) and hepatic metastases of patients with metastatic PanNETs to the liver, thus facilitating surgical resection.
Measured: 2 Years
Increase in Progression Free Survival
To determine whether PRRT plus cytoreductive surgery increases PFS when compared to a historical cohort of patients undergoing PRRT only for metastatic PanNETs.
Measured: 2 years
Improvement in Progression-Free Survival (PFS2)
To determine whether PRRT plus cytoreduction compared to cytoreduction alone followed by PRRT once progression has occurred improves progression-free survival (PFS2)
Measured: 2 years
Improvement in Overall Survival
To determine whether PRRT plus cytoreduction compared to cytoreduction alone followed by PRRT once progression has occurred improves Overall Survival.
Measured: 2 years
Difference in imaging characteristics
To determine differences in imaging characteristics (e.g. tumor size), biochemical and molecular signatures of patients having received surgery + PRRT or surgery alone.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start7 Mar 2023
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Why it stopped: 0 enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Keutgen, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610826
- Sponsor's protocol ID
- IRB19-1485
- Status last verified
- Jan 2024
- First submitted
- 2 Nov 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative PRRT Versus Surgical Cytoreduction Alone in Metastatic Pancreatic Neuroendocrine Tumors to the Liver: A Phase II Multi-institutional Trial
- ClinicalTrials.gov ID
- NCT05610826
- Acronym / sponsor ID
- IRB19-1485
- Conditions
- Pancreatic Neuroendocrine Tumor, Pancreas Cancer
- Keywords
- pancreatic cancer, pancreas cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. PRRT itself is approved by the U.S. Food and Drug Administration (FDA) for people with PanNETs however the combination with cytoreduction is considered experimental.
Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
Detailed description
Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. PRRT itself is approved by the U.S. Food and Drug Administration (FDA) for people with PanNETs however the combination with cytoreduction is considered experimental.
Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
PRRT is a form of targeted treatment (think of a "lock and key") done by the use of a small molecule (Lutathera) Lutathera acts as a "key" to "lock" onto certain areas your tumor cells called receptors when injected into a vein and travels through the bloodstream. Lutetium-177 is the radionuclide in Lutathera which is a chemical that delivers strong radiation directly into your tumor cells and works by causing death of the cancerous tissues.
PRRT can only be done on patients who have tumors that have the somatostatin receptors. Before being given PRRT, your treating doctor will run imaging tests to make sure your tumors have these targeted receptors. Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
Participants will be randomized (like the flip of a coin) to one of two arms. Arm 1 is the control arm, which will undergo standard of care cytoreductive surgery (for the tumor). Arm 2 will undergo four cycles of PRRT before cytoreductive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Control Arm - Standard Of Care - no peptide receptor radionuclide therapy | Other | Procedure: cytoreductive surgeryArm 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). |
| Arm 2 (peptide receptor radionuclide therapy + cytoreductive surgery) | Experimental | Procedure: cytoreductive surgery, Drug: Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT), Procedure: Peptide receptor radionuclide therapy (PRRT)Arm 2 will undergo four cycles of peptide receptor radionuclide therapy (PRRT) before cytoreductive surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Metastatic Pancreatic neuroendocrine tumors (PanNET) to the liver
- Well- or moderately differentiated (grade 1 or grade 2, Ki-
- Ability to aim for equal or greater than 90% hepatic cytoreduction surgically
- Proof of SSTR2 expression by uptake of tumor on 68Ga DOTATATE PET CT (Krenning Score on all or a majority of lesions
- Age older than 18 years
Key exclusion criteria (21 listed)
- Patient with G3 or poorly differentiated NET (grade 3, Ki-67 >20%)
- Previous liver-directed therapy with Yttrium-90 (TACE/TAE allowed if performed more than 12 months prior to enrollment)
- Systemic therapy with Capecitabine and/or Temozolamide within 12 months of enrollment.
- No tumor uptake on 68Ga DOTATATE PET CT
- Liver tumor burden > 50% (as defined by CT or MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytoreductive surgeryCytoreductive surgery is an operation to remove as much tumor tissue as possible. | Procedure or surgery | Arm 1- Control Arm - Standard Of Care - no peptide receptor radionuclide therapy, Arm 2 (peptide receptor radionuclide therapy + cytoreductive surgery) |
| Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT)PRRT is a form of targeted treatment (think of a "lock and key") done by the use of a small molecule (Lutathera). Lutathera acts as a "key" to "lock" onto certain areas your tumor cells called receptors when injected into a vein and travels through blood. | Drug | Arm 2 (peptide receptor radionuclide therapy + cytoreductive surgery) |
| Peptide receptor radionuclide therapy (PRRT)PRRT is a molecular targeted therapy used to treat neuroendocrine tumors (NET). Molecular targeted therapies use drugs or other substances to identify and attack cancer cells while reducing harm to healthy tissue. PRRT delivers high doses of radiation to tumors in the body to destroy or slow their growth and reduce disease side effects. | Procedure or surgery | Arm 2 (peptide receptor radionuclide therapy + cytoreductive surgery) |
Primary outcome
Progression-free Survival
Time frame: 2 years
To determine whether preoperative peptide receptor radionuclide therapy (PRRT) prior to hepatic cytoreduction increases progression free survival (PFS1) (when compared to cytoreduction alone) in patients with metastatic PanNETs to the liver
6 secondary outcomes
Overall Survival
Time frame: 2 years
Objective Response Rate
Time frame: 2 Years
Increase in Progression Free Survival
Time frame: 2 years
Improvement in Progression-Free Survival (PFS2)
Time frame: 2 years
Improvement in Overall Survival
Time frame: 2 years
Difference in imaging characteristics
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Keutgen, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cytoreductive surgery, Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT) and Peptide receptor radionuclide therapy (PRRT) in people with Pancreatic Neuroendocrine Tumor and Pancreas Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.