Clinical trial NCT02841865: Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria
Official title: Evaluation of Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neuroendocrine Tumors
Lead sponsor: Grupo Espanol de Tumores Neuroendocrinos
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Response to treatment
timeFrame: 3 months
Secondary outcomes:
measure: Progression Free Survival on partial response
timeFrame: 3 months
measure: Progression Free Survival on Stable Disease
timeFrame: 3 months
measure: Impact of Tumor Uptake on Response to Treatment
timeFrame: 3 months
measure: Impact of Response to Treatment and Progression Free Survival
timeFrame: 3 months
measure: Impact of Choi criteria and Progression of Disease
timeFrame: 3 months
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Universitario Central de Asturias
name: María del Pilar Solís Hernández, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Central de Asturias
name: Paula Jiménez Fonseca, M.D.
role: STUDY_CHAIR
affiliation: Hospital Universitario Central de Asturias
name: David Calvo Temprano, M.D.
role: STUDY_CHAIR
References: