Phase 4
N=51
A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide
Neuroendocrine Tumors
Bottom Line
View on ClinicalTrials.gov: NCT03289741 ↗Enrolled (actual)
51
Serious AEs
20.6%
Results posted
May 2025
Primary outcome: Primary: Mean Pain Scores at 3 Months — 2.4; 2.4; 1.9; 1.9 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Octreotide (Drug); LAR Lanreotide (Drug); Questionnaires (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Scores at 3 Months |
2.4; 2.4; 1.9; 1.9 | — |
Summary
This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03289741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.