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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT03289741 (opens ClinicalTrials.gov in a new tab)Other id17-422
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
51 participants (actual)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
19 Sept 2017
Primary completion
10 Apr 2023
Completion
10 Apr 2023
First posted
21 Sept 2017
Last update posted
9 May 2025
Conditions
Neuroendocrine Tumors

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph 4

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

    NCT03289741

    19 Sept 2017 to 10 Apr 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • OctreotideDrug
  • LAR LanreotideDrug
  • QuestionnairesBehavioral

Arms2

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Pain Scores at 3 Months

    Time frame · 3 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months

Mean Pain Scores at 3 Months

GroupValue (scores on a scale)
Octreotide Then Lanreotide2.4
Lanreotide Then Octreotidenot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OctreotideEach 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. Participants are assigned to one arm of the study and they remain on that arm for the duration of the study. Octreotide: Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections LAR Lanreotide: Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections Questionnaires: Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.13 / 5113 / 510 / 51
LanreotideEach patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections. Participants are assigned to one arm of the study and they remain on that arm for the duration of the study. Octreotide: Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections LAR Lanreotide: Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections Questionnaires: Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.8 / 518 / 510 / 51

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

3 results

A Randomized Trial Evaluating Patient Experience and Preference Between Octreotide Long-Acting Release and Lanreotide for Treatment of Well-Differentiated Neuroendocrine Tumors.

Raj et al. 2022JCO oncology practicecited by 4

PMID 35724357PMC9509059DOI 10.1200/op.22.00055PUB-35724357

Rights unknown3 results
Source linkSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: * 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

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