Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria

Study Overview
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Brief Summary
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The Response Evaluation Criteria in Solid Tumors (RECIST), based on differences in tumor size, has been considered as a reproducible method that facilitates not only the measurement of the mass but the evaluation of response to given treatments; while classic chemotherapy induces a reduction of the tumor, new target therapies frequently produce the stabilization of the disease or a delayed progression. These new therapeutic alternatives have shade light on the limitations of the RECIST criteria, since the response to these type of treatments are basically associated with changes on the radiological characteristics of the tumor, as well as other findings in functional imaging. This study is aimed to compare the response rates according both Choi and RECIST criteria.

Official Title
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Evaluation of Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria

Conditions
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Pancreatic Neuroendocrine Tumors

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a pancreatic neuroendocrine tumor with a Ki67 index <20%, who accept to participate and sign the consent form. In case of death patients, waiver of consent has been considered. Patients who, according daily clinical practice, have been treated with sunitinib between February 2012 to end of inclusion period, with a follow up of at least 6 months. Patients with a baseline imaging study (TC with arterial phase) and, at least, a 6-months follow-up evaluation. Patients with progression or exitus before the first imaging evaluation will not be included. Exclusion Criteria: Patients with a follow-up of <6months because of any other cause beyond progression of disease or exitus. Patients without a baseline radiological evaluation or at 3/6 months. Patients who do not accept to participate in the study. Patients with anti-angiogenic treatment within 3 months prior to the start of sunitinib treatment. Patients treated with sunitinib plus any other anti-proliferative agent beyond ASS.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment | According Choi and RECIST Criteria | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival on partial response | Time between start of treatment and progression of disease in patients with partial response | 3 months | 
| Progression Free Survival on Stable Disease | Time between start of treatment and progression of disease in patients with stable disease | 3 months | 
| Impact of Tumor Uptake on Response to Treatment | Description of the uptake of pancreatic neuroendocrine tumor lesions in the arterial phase (baseline evaluation), and assessment of a possible correlation with the response to treatment using the RECIST criteria. | 3 months | 
| Impact of Response to Treatment and Progression Free Survival | Description of the uptake of pancreatic neuroendocrine tumor lesions in the arterial phase and assess ment of a possible correlation with the progression free survival. | 3 months | 
| Impact of Choi criteria and Progression of Disease | Correlation of Changes on the uptake of pancreatic neuroendocrine tumor lesions in the arterial phase and progression of disease. | 3 months |