Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT01603004|
Recruitment Status : Recruiting
First Posted : May 21, 2012
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment|
|Pancreatic Neuroendocrine Cancer||Other: MRI|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||A Pilot Study to Identify Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors|
|Actual Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
everolimus, sunitinib or traditional chemotherapy
A total of 30 patients with well differentiated pancreatic NETs who have known liver metastases and who are planned to initiate therapy with either targeted (everolimus or sunitinib) or traditional cytotoxic chemotherapy will be recruited for this study. We plan to recruit approximately 10 patients for each therapy (everolimus, sunitinib, cytotoxic chemotherapy). Evidence of metastatic disease will be determined at the discretion of the oncologist based on available imaging, surgical and pathologic evidence.
Patients will be treated with either sunitinib, everolimus, or traditional chemotherapy according to standard of care. Follow-up with imaging (either MRI or CT) will be performed approximately every 3 months. Unidimensional tumor measurement on standard CT and MRI sequences will be performed, according to guidelines from RECIST v1.1, which will be used to assess for progression of disease. Patients will be followed for up to 5 years. Upon evidence of disease progression, patients will be asked to undergo a post-treatment biopsy. If medically possible and safe, they will stay on the drug until the time of biopsy.
- Progression free survival [ Time Frame: 2 years ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
- Overall survival [ Time Frame: 5 years ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
- best response [ Time Frame: 5 years ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603004
|Contact: Nitya Raj, MD||646-888-4849|
|Contact: Kinh Gian Do, MD, Phd||212-639-8591|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Nitya Raj, MD 646-888-4849|
|Contact: Kinh Gian Do, MD, PhD 212-639-8591|
|Principal Investigator: Nitya Raj, MD|
|Principal Investigator:||Nitya Raj, M.D||Memorial Sloan Kettering Cancer Center|