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

Study Overview
=================
Brief Summary
-----------------
This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.

Official Title
-----------------
A Pilot Study To Evaluate Patient Experience With the Somatostatin Analogs Octreotide Long Acting Release and Lanreotide During the Treatment of Advanced, Nonfunctional, Well Differentiated Neuroendocrine Tumors

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Drug: Octreotide
* Drug: LAR Lanreotide
* Behavioral: Questionnaires


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two-arm randomized design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide then Lanreotide<br>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<br>* Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections<br>Drug: LAR Lanreotide<br>* Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections<br>Behavioral: Questionnaires<br>* Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.<br>|
| Experimental: Lanreotide then Octreotide<br>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<br>* Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections<br>Drug: LAR Lanreotide<br>* Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections<br>Behavioral: Questionnaires<br>* Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of mean pain scores | 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. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
17-422, Octreotide, Lanreotide