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Trial record 5 of 128 for:    "Pancreatic Neuroendocrine Tumor"

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

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ClinicalTrials.gov Identifier: NCT02841865
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de Tumores Neuroendocrinos

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.


Condition or disease
Pancreatic Neuroendocrine Tumors

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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Radiological Response of Pancreatic Neuroendocrine Tumors: Comparison Between the Choi and the RECIST Criteria
Actual Study Start Date : August 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018





Primary Outcome Measures :
  1. Response to treatment [ Time Frame: 3 months ]
    According Choi and RECIST Criteria


Secondary Outcome Measures :
  1. Progression Free Survival on partial response [ Time Frame: 3 months ]
    Time between start of treatment and progression of disease in patients with partial response

  2. Progression Free Survival on Stable Disease [ Time Frame: 3 months ]
    Time between start of treatment and progression of disease in patients with stable disease

  3. Impact of Tumor Uptake on Response to Treatment [ Time Frame: 3 months ]
    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.

  4. Impact of Response to Treatment and Progression Free Survival [ Time Frame: 3 months ]
    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.

  5. Impact of Choi criteria and Progression of Disease [ Time Frame: 3 months ]
    Correlation of Changes on the uptake of pancreatic neuroendocrine tumor lesions in the arterial phase and progression of disease.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841865


Locations
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Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 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 Virgen del Rocio
Sevilla, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Grupo Espanol de Tumores Neuroendocrinos
Investigators
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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

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Responsible Party: Grupo Espanol de Tumores Neuroendocrinos
ClinicalTrials.gov Identifier: NCT02841865     History of Changes
Other Study ID Numbers: GET-SUN-2015-01
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases