Return to Clinical Trials Search Results
A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and Nab-paclitaxel for Locally Advanced Pancreatic Cancer
Primary Objectives
To determine if intensified radiochemotherapy following gemcitabine and nab-Paclitaxel in patients with unresectable pancreatic cancer will show a signal for improved 2-year OS from 10% to 22.5% as compared to chemotherapy with gemcitabine and nab-Paclitaxel alone.
To determine if standard radiochemotherapy, following gemcitabine and nab-Paclitaxel, in patients with unresectable pancreatic cancer will show a signal for improved 2-year OS from 10% to 22.5% as compared to chemotherapy with gemcitabine and nab-Paclitaxel alone.
Secondary Objectives
To evaluate patterns of failure (local and systemic progression) by SMAD4 status and intensity of radiation therapy
To evaluate the impact of radiochemotherapy on OS for the subset of SMAD4 intact patients
To evaluate adverse events associated with the treatments.
To evaluate correlation between SMAD4 status determined by IHC and genetic SMAD4 status.
Primary Objectives
To determine if intensified radiochemotherapy following gemcitabine and nab-Paclitaxel in patients with unresectable pancreatic cancer will show a signal for improved 2-year OS from 10% to 22.5% as compared to chemotherapy with gemcitabine and nab-Paclitaxel alone.
To determine if standard radiochemotherapy, following gemcitabine and nab-Paclitaxel, in patients with unresectable pancreatic cancer will show a signal for improved 2-year OS from 10% to 22.5% as compared to chemotherapy with gemcitabine and nab-Paclitaxel alone.
Secondary Objectives
To evaluate patterns of failure (local and systemic progression) by SMAD4 status and intensity of radiation therapy
To evaluate the impact of radiochemotherapy on OS for the subset of SMAD4 intact patients
To evaluate adverse events associated with the treatments.
To evaluate correlation between SMAD4 status determined by IHC and genetic SMAD4 status.
Recruitment Status
Past Studies