Radiological Response Of Pancreatic Neuroendocrine Tumors: Comparison Between The Choi And The RECIST Criteria

Study Overview

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

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.

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Pancreatic Neuroendocrine Tumors

GET-SUN-2015-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-07-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-03-23
First Submitted that Met QC Criteria 2016-07-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-03-24
First Posted (ACTUAL) 2016-07-22	Results First Posted N/A	Last Verified 2019-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Response to treatment	According Choi and RECIST Criteria	3 months

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: María del Pilar Solís Hernández, M.D., Hospital Universitario Central de Asturias

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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