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CompletedNCT03289741Updated May 9, 2025Results posted

A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide

A Phase 4 interventional study of Octreotide and LAR Lanreotide in Neuroendocrine Tumors, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.

02

Conditions studied

  • Neuroendocrine Tumors

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Keywords

  • Octreotide
  • Lanreotide
  • 17-422
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Willing and able to provide written informed consent for the trial
  • ≥ 18 years of age
  • Histologically- or cytologically- confirmed locally advanced or metastatic WDNET
  • SSA therapy is recommended by physician for disease management, and has not yet begun
  • ECOG performance status of 0, 1, or 2

Exclusion criteria

Exclusion Criteria:

  • Currently participating in a study of an investigational agent
  • Prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

    *Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study

  • No concurrent chemotherapy or targeted small molecule therapy
  • If received major surgery, not recovered adequately from the toxicity and/or complications from the intervention prior to starting the study
  • Known additional malignancy that is progressing or requires active treatment
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Octreotide then Lanreotide

    Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections

    Drug: Octreotide · Drug: LAR Lanreotide · Behavioral: Questionnaires

  • Experimental
    Lanreotide then Octreotide

    Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections

    Drug: Octreotide · Drug: LAR Lanreotide · Behavioral: Questionnaires

Interventions

  • DrugOctreotide

    Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections

  • DrugLAR Lanreotide

    Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections

  • BehavioralQuestionnaires

    Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.

05

What researchers measure

Primary outcomes

  1. Mean Pain Scores at 3 Months

    Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.

    Time frame: 3 months

06

Results

Posted May 9, 2025

Participant flow

Participant flow — Overall Study
MilestoneOctreotide Then LanreotideLanreotide Then Octreotide
Started2625
Completed2222
Not completed43
Withdrew: Adverse event11
Withdrew: Physician decision22
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryMean Pain Scores at 3 Months

Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.

Time frame:
3 months
Reported as:
Mean · scores on a scale
Mean Pain Scores at 3 Months
scores on a scaleOctreotide Then LanreotideLanreotide Then Octreotide
Octreotide, first intervention (3 months)2.4 (0 to 10)—
Lanreotide, second intervention (6 months)2.4 (0 to 10)—
Lanreotide, first intervention (3 months)—1.9 (0 to 10)
Octreotide, second intervention (6 months)—1.9 (0 to 10)

Adverse events

Collected over Up to 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Octreotide13/51 (25.5%)13/51 (25.5%)0/51 (0%)
Lanreotide8/51 (15.7%)8/51 (15.7%)0/51 (0%)
Most frequent serious events
Most frequent serious events
EventOctreotideLanreotide
Death NOSGeneral disorders13/518/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)Octreotide Then LanreotideLanreotide Then OctreotideTotal
Mean63 (40 to 83)67 (47 to 87)65 (40 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)Octreotide Then LanreotideLanreotide Then OctreotideTotal
Female111526
Male151025
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Octreotide Then LanreotideLanreotide Then OctreotideTotal
Hispanic or Latino112
Not Hispanic or Latino232144
Unknown or Not Reported235
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Octreotide Then LanreotideLanreotide Then OctreotideTotal
American Indian or Alaska Native000
Asian303
Native Hawaiian or Other Pacific Islander000
Black or African American044
White211940
More than one race112
Unknown or Not Reported112
Region of Enrollment
Region of Enrollment(Participants)Octreotide Then LanreotideLanreotide Then OctreotideTotal
United States262551
07

Study locations

7 sites
  • Memorial Sloan Kettering Basking Ridge
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Monmouth
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Bergen
    Montvale, New Jersey 07645, United States
  • Memorial Sloan Kettering Commack
    Commack, New York 11725, United States
  • Memorial Sloan Kettering West Harrison
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Memorial Sloan Kettering Nassau
    Uniondale, New York 11553, United States
08

References and documents

Publications

  • Raj N, Cruz E, O'Shaughnessy S, Calderon C, Chou JF, Capanu M, Heffernan O, DeMore A, Punn S, Le T, Hauser H, Saltz L, Reidy-Lagunes D. A Randomized Trial Evaluating Patient Experience and Preference Between Octreotide Long-Acting Release and Lanreotide for Treatment of Well-Differentiated Neuroendocrine Tumors. JCO Oncol Pract. 2022 Sep;18(9):e1533-e1541. doi: 10.1200/OP.22.00055. Epub 2022 Jun 20. PubMed 35724357 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 20, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03289741
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Sep 19, 2017
Primary completion
Apr 10, 2023
Completion
Apr 10, 2023
Results posted
May 9, 2025
Last update
May 9, 2025

Study contacts

Nitya Raj, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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