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

NCT ID: NCT02841865

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-24

Study Completion Date

2018-04-30

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.

Detailed Description

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Conditions

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Pancreatic Neuroendocrine Tumors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Espanol de Tumores Neuroendocrinos

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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María del Pilar Solís Hernández, M.D.

Role: STUDY_CHAIR

Hospital Universitario Central de Asturias

Paula Jiménez Fonseca, M.D.

Role: STUDY_CHAIR

Hospital Universitario Central de Asturias

David Calvo Temprano, M.D.

Role: STUDY_CHAIR

Hospital Universitario Central de Asturias

Locations

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Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Universitario Morales Meseguer

Murcia, , Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status

Complejo Hospitalario de Navarra

Pamplona, , Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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GET-SUN-2015-01

Identifier Type: -

Identifier Source: org_study_id

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