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Completed

NCT Number: NCT02841865

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.

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Key information

Conditions

Pancreatic Neuroendocrine Tumors

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Response to treatment

    Time frame: 3 months

    According Choi and RECIST Criteria

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Grupo Espanol de Tumores Neuroendocrinos

Other

Registry information

Official study title

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

Acronym: CRIPNET

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 22, 2016
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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