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

Evaluation of 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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neuroendocrine Tumors

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal
  • Murcia, Spain
    • Hospital Universitario Morales Meseguer
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias
  • Pamplona, Spain
    • Complejo Hospitalario de Navarra
  • Sevilla, Spain
    • Hospital Universitario Virgen Del Rocio
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet
  • Cantabria
    • Santander, Cantabria, Spain
      • Hospital Universitario Marqués de Valdecilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Grupo Espanol de Tumores Neuroendocrinos
• Investigators: Study Chair: 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 record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2015
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (ESTIMATE): July 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Adenoma; Pancreatic Neoplasms; Neuroendocrine Tumors; Adenoma, Islet Cell
• Other Study ID Numbers: GET-SUN-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO