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

Pancreatic Neuroendocrine Tumors Clinical Trial

— CRIPNET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841865
• Other study ID #: GET-SUN-2015-01
• Status: Completed
• Start date: July 24, 2015
• Est. completion date: April 2018

Study information

• Verified date: July 2019
• Source: Grupo Espanol de Tumores Neuroendocrinos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumors

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Morales Meseguer	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol de Tumores Neuroendocrinos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment	According Choi and RECIST Criteria	3 months
Secondary	Progression Free Survival on partial response	Time between start of treatment and progression of disease in patients with partial response	3 months
Secondary	Progression Free Survival on Stable Disease	Time between start of treatment and progression of disease in patients with stable disease	3 months
Secondary	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
Secondary	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
Secondary	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