High or Standard Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-paclitaxel in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

Brief summary public domain (ClinicalTrials.gov)

This randomized phase II trial studies how well high or standard intensity radiochemotherapy after gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) work compared with gemcitabine hydrochloride and nab-paclitaxel alone in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving radiation therapy in different ways and adding chemotherapy may kill more tumor cells. It is not yet known whether high intensity radiochemotherapy after gemcitabine hydrochloride and nab-paclitaxel is more effective than standard intensity radiochemotherapy after gemcitabine hydrochloride and nab-paclitaxel or gemcitabine hydrochloride and nab-paclitaxel alone in treating pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: * I. To determine if intensified radiochemotherapy following gemcitabine and nab-paclitaxel in patients with unresectable pancreatic cancer will show a signal for improved 2-year overall survival (OS) from 10% to 22.5% as compared to chemotherapy with gemcitabine and nab-paclitaxel alone. * II. 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: * I. To evaluate patterns of failure (local and systemic progression) by SMAD family member 4 (SMAD4) status and intensity of radiation therapy. * II. To evaluate the impact of radiochemotherapy on OS for the subset of SMAD4 intact patients. * III. To evaluate adverse events associated with the treatments. * IV. To evaluate correlation between SMAD4 status determined by immunohistochemistry (IHC) and genetic SMAD4 status. Patients are randomized to 1 of 3 treatment arms. After completion of study treatment, patients are followed up at 1 month and then every 3 months.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival [From randomization until last follow-up. Analysis was to occur after a total of 140 deaths were reported within the pairing of each radiation arm with the chemotherapy alone arm. Maximum follow-up at time of study termination was 8.3 months.]. Count Of Participants, Participants. Chemotherapy + High Intensity Radiation (n=4): 4; Chemotherapy + Low Intensity Radiation (n=4): 4; Chemotherapy (n=5): 5.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival Within SMAD4 Subsets [From randomization until last follow-up. Analysis was to occur after a total of 140 deaths were reported within the pairing of each radiation arm with the chemotherapy alone arm. Maximum follow-up at time of study termination was 8.3 months.]. Count Of Participants, Participants. Intact: Chemotherapy + High Intensity Radiation (n=4): 1; Chemotherapy + Low Intensity Radiation (n=4): 1; Chemotherapy (n=5): 3. Loss: Chemotherapy + High Intensity Radiation (n=4): 3; Chemotherapy + Low Intensity Radiation (n=4): 2; Chemotherapy (n=5): 1. Undetermined: Chemotherapy + High Intensity Radiation (n=4): 0; Chemotherapy + Low Intensity Radiation (n=4): 1; Chemotherapy (n=5): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Patterns of Failure (Local and Metastatic Failure) [From randomization until last follow-up. Maximum follow-up at time of study termination was 8.3 months.]. Count Of Participants, Participants. Local Failure: Chemotherapy + High Intensity Radiation (n=1): 0; Chemotherapy + Low Intensity Radiation (n=2): 0. Metastatic Failure: Chemotherapy + High Intensity Radiation (n=1): 0; Chemotherapy + Low Intensity Radiation (n=2): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Correlation Between SMAD4 Status Determined by Immunohistochemistry (IHC) and Genetic SMAD4 Status [Baseline].