Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates

Brief summary public domain (ClinicalTrials.gov)

The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).

Detailed description public domain (ClinicalTrials.gov)

Patients in both cohorts will receive a total of 3 cycles of neoadjuvant combination chemotherapy of nab-paclitaxel and gemcitabine, followed by re-staging CT scan, if re-staging CT does not show evidence of metastatic disease. Patients will receive SBRT and definitive surgical resection. Subsequently, patients will receive 3 cycles of adjuvant combination chemotherapy of nab-paclitaxel and gemcitabine. Each cycle of combination chemotherapy will be a total of 4 weeks. Patients will be evaluated for response at completion of the 3 cycles of neoadjuvant combination chemotherapy with CT scans of chest, abdomen and pelvis. Patients will undergo surveillance CT scan at 3-month intervals until evidence of disease progression.

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

R0 Resection Rates in Each Cohort as Measured by Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins [at the time of surgery]. Number, participants with resectable PDAC. Nab-paclitaxel/Gemcitabine for R-PDAC (n=19): 9; Nab-paclitaxel/Gemcitabine for BR-PDAC (n=29): 9.

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

Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v.4.03 [24 months]. Count Of Participants, Participants. Nab-paclitaxel/Gemcitabine for R-PDAC (n=19): 19; Nab-paclitaxel/Gemcitabine for BR-PDAC (n=29): 29.

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

Median Overall Survival [Up to 74 months]. Median, months (Full Range). Nab-paclitaxel/Gemcitabine for R-PDAC (n=19): 17.4 (5.2 to 53.6); Nab-paclitaxel/Gemcitabine for BR-PDAC (n=29): 15.5 (1 to 73.7).