A RANDOMIZED PHASE III BLINDED TRIAL OF LANREOTIDE FOR THE PREVENTION OF POSTOPERATIVE PANCREATIC FISTULA
Study on Investigational Medication for Preventing Pancreatic Fluid Leakage After Surgery
Ryan Ellis
Primary Investigator
Brief description of study
Primary Objectives- To compare the incidence of postoperative pancreatic fistula (POPF) occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm
Secondary Objectives-a. To compare the incidence of International Study Group of Pancreatic Surgery (ISGPS)-defined Biochemical Leak occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo in the subset of participants with a drain placed.
b. To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo.
c. To compare change from baseline in cancer-specific quality of life at 14 and 60 days after surgery, as measured by the EORTC QLQ-C30, in participants randomized to receive preoperative lanreotide versus placebo
Detailed description of study
Initiation of study intervention with lanreotide/placebo and planned elective distal pancreatectomy must be planned to be completed no more than 60 calendar days after registration/randomization.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pancreatic Cancer
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Age: 18 years - 100 years
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Gender: All
Prior to registration/randomization, participants must meet the f ollowing criteria:
5.1. Disease Related Criteria
a. Participants must have histologically or radiographically confirmed diagnosis of
pancreatic cancer or a pancreatic lesion with malignant potential.
b. Participants must have an elective distal pancreatectomy planned to occur within
60 days af ter registration/randomization date.
c. Participants must not have a known history of a prior diagnosis of malabsorption
syndrome.
5.2. Prior/Concurrent Therapy Criteria
a. Participants must not have been treated with any somatostatin analogue within
180 days prior to registration/randomization.
b. Participants must not have been treated with radiation therapy for their pancreas
malignancy at any time prior to registration/randomization.
c. Participants must not have been treated with peptide receptor radionuclide therapy
(PRRT) at any time prior to registration/randomization.
5.3. Clinical/Laboratory Criteria
a. Participants must be ≥ 18 years old.
b. Participants must have a complete documented medical history and physical exam
within 28 days prior to registration/randomization.
c. Participants must have a creatinine ≤ the IULN OR a measured OR calculated
creatinine clearance ≥ 50 mL/min using the f ollowing Cockcroft-Gault Formula
within 60 days prior to registration/randomization:
Calculated Creatinine Clearance = (140 - age) X (weight in kg) †
72 x creatinine *
Multiply this number by 0.85 if the participant is biologically f emale.
† The kilogram weight is the participant weight with an upper limit of 140% of the
IBW.
* Actual lab creatinine value with a minimum of 0.7 mg/dL.
d. Participants must complete a pre-registration screening to identify any of the
medications below, allowing the study team and treating physician to develop a
monitoring plan as needed. Participants taking medications with known interactions
with lanreotide may remain eligible if appropriate monitoring and management are in
place. These medications include:
• Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be
monitored, and medication dose adjustments made as needed.
• Cyclosporine: Dosage adjustments may be required to maintain
therapeutic levels.
• Bromocriptine: Dose adjustments may be considered to account for
absorption changes.
• Heart medications (e.g., beta blockers): Heart rate will be monitored, and
medication doses adjusted if necessary.
• CYP3A4-metabolized medications: Dose adjustments may be considered
to avoid increased exposure.
e. In the opinion of the treating surgeon, based on preoperative data, the participant
must not require a modified Appleby-type procedure (distal pancreatectomy with
celiac axis resection) or multivisceral resection (e.g., stomach, colon, etc.) at the
time of distal pancreatectomy.
NOTE: planned removal of the gallbladder or spleen at the time of distal
pancreatectomy is not considered multivisceral resection and is permissible.
f. In the opinion of the treating surgeon, based on preoperative data, the participant
must not require a tumor enucleation.
g. Participants must not have moderate to severe hepatic impairment as defined by
liver enzyme elevation more than 5 times the institutional upper limit of normal
(either AST >190 U/L or ALT >320 U/L) within 60 days prior to
registration/randomization. Transient elevation at the time of screening that
resolves prior to study enrollment is acceptable.
h. Participants must not be pregnant or nursing (nursing includes breast milk fed to an
inf ant by any means, including from the breast, milk expressed by hand, or pumped).
i. Individuals who are of reproductive potential must have agreed to use an effective
contraceptive method during the whole period of the study and for three months after
the study drug administration, with details provided as a part of the consent process.
A person who has had menses at any time in the preceding 12 consecutive months or
who has semen likely to contain sperm is considered to be of "reproductive
potential." In addition to routine contraceptive methods, "effective contraception" also
includes refraining from sexual activity that might result in pregnancy and surgery
intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including
hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and
vasectomy with testing showing no sperm in the semen.
5.4. Specimen Submission Criteria
a. Participants must be offered the opportunity to participate in specimen banking
5.5. Quality of Lif e Submission Criteria
a. Participants who can complete EORTC QLQ-C30, EORTC QLQ-PAN26, and EQ-5D-
5L f orms in English or Spanish, must be offered the opportunity to participate in the
Quality-of -Lif e study as outlined in Section 7.6 and Section 15.5 .
5.6. Regulatory Criteria
NOTE: As a part of the OPEN registration process (see Section 13.5 f or OPEN access
instructions) the treating institution’s identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been entered
in the system.
a. Participants must be informed of the investigational nature of this study and must
sign and give inf ormed consent in accordance with institutional and f ederal
guidelines.
b. For participants with impaired decision-making capabilities, legally authorized
representatives may sign and give informed consent on behalf of study participants
in accordance with applicable f ederal, local, and CIRB regulations
This study investigates the use of an investigational medication to prevent postoperative pancreatic fistula (POPF) in patients undergoing distal pancreatectomy. POPF is a complication that can occur after surgery on the pancreas, where pancreatic fluid leaks from the surgical site. The study aims to compare the incidence of POPF in patients who receive the investigational medication before surgery with those who receive a placebo.
Participants in the study will be randomly assigned to one of two study arms: one receiving the investigational medication and the other receiving a placebo. The study will involve monitoring the occurrence of POPF and other complications within 60 days post-surgery. Participants will also have their quality of life assessed using specific questionnaires before and after the surgery.
- Who can participate: Adults 18 and older with pancreatic cancer or a pancreatic lesion with malignant potential are eligible. They must have an elective distal pancreatectomy planned and no history of malabsorption syndrome or recent treatment with certain medications.
- Study details: Participants will receive either the investigational medication or a placebo before surgery. The investigational medication aims to reduce complications after surgery.
- Study timelines: The study will last 60 days.