Chemoimmunotherapy and Radiation in Pancreatic Cancer (CRIT)
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|ClinicalTrials.gov Identifier: NCT01903083|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Malignant Neoplasm||Drug: Tadalafil Drug: Gemcitabine Radiation: Radiation Procedure: Pancreaticoduodenectomy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Chemoimmunotherapy and Hypofractionated Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma.|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Immunotherapy with oral tadalafil daily; three doses of chemotherapy with IV Gemcitabine in 21-day cycles for up to 4 cycles; three fractions of external beam radiation to the pancreas and and regional lymph nodes; pancreaticoduodenectomy (surgical resection) for eligible patients.
One 2.5 mg tablet is self-administered orally by the study participant on a once daily basis.
Other Name: Cialis
Three doses of gemcitabine (1000 mg / m^2)are given over a 21-day cycle. Patients may receive up to 4 cycles.
Other Name: Gemzar
Patients will receive 3 doses of radiation (8-10 Gy per fraction).
- Safety [ Time Frame: 135 Days ]Patients will return be seen in the clinic 8 times over the first 50 days for an evaluation of adverse events and toxicities before being evaluated for surgery. Patients who are not candidates for surgery will be seen in clinic 10 more times over the next 85 days for safety evaluations, and patients who have surgery will be seen 10 times over the 85 days following recovery from surgery for safety evaluations.
- Immune Infiltration in pancreaticoduodenectomy tissue [ Time Frame: 50 Days ]For surgery patients, formalin fixed and paraffin-embedded tumor tissue obtained during surgery will be sectioned and immunohistology performed to determine the tumor inflammatory micro-environment and the degree of macrophage and T cell inflammation.
- Quantification of T cells in peripheral blood pre- and post-treatment [ Time Frame: 135 Days ]Patients will provide a pre-treatment blood sample and 4 blood samples over 135 days to evaluate the influence of the study treatment on immune parameters. For patients who have surgery, the time period will be longer depending on their recovery time. Post-treatment long term follow up will occur every 12 weeks (+/- 2 weeks) beyond post-recovery date (PRD) 85 for 6 visits. Blood will be collected for immune monitoring at each visit.
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): NCT01903083
|United States, Oregon|
|Portland Providence Medical Center|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Todd Crocenzi, MD||Providence Health & Services|