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

NCT02841865 | Completed

• 1 other identifier: GET-SUN-2015-01
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Pancreatic Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Response to treatment

  According Choi and RECIST Criteria

  3 months

Secondary Outcomes (5)

• Progression Free Survival on partial response

  3 months

• Progression Free Survival on Stable Disease

  3 months

• Impact of Tumor Uptake on Response to Treatment

  3 months

• Impact of Response to Treatment and Progression Free Survival

  3 months

• Impact of Choi criteria and Progression of Disease

  3 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a neuroendocrine pancreatic tumor, treated with sunitinib, with at least one radiological evaluation every 6 months.

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Espanol de Tumores Neuroendocrinos: lead

Study Sites (10)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Morales Meseguer

Murcia, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Study Officials

• María del Pilar Solís Hernández, M.D.

  Hospital Universitario Central de Asturias

  STUDY CHAIR

• Paula Jiménez Fonseca, M.D.

  Hospital Universitario Central de Asturias

  STUDY CHAIR

• David Calvo Temprano, M.D.

  Hospital Universitario Central de Asturias

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: July 24, 2015
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: March 24, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)