A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide
NCT ID: NCT03289741
Last Updated: 2025-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
51 participants
INTERVENTIONAL
2017-09-19
2023-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nitya Raj, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering West Harrison
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-422
Identifier Type: -
Identifier Source: org_study_id
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