Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01603004|
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment|
|Pancreatic Neuroendocrine Cancer||Other: MRI|
|Study Type :||Observational|
|Actual Enrollment :||25 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 14, 2012|
|Actual Primary Completion Date :||June 24, 2019|
|Actual Study Completion Date :||June 24, 2019|
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.
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): NCT01603004
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Nitya Raj, M.D||Memorial Sloan Kettering Cancer Center|