Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery ("Personalized Medicine")

Brief summary public domain (ClinicalTrials.gov)

In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular profiling). The results of the test are used by the doctor to recommend therapy (chemotherapy and radiation therapy) that the patient will receive before having surgery to remove the adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is removed is tested again. The results of that test are used to guide the choice of therapy after surgery. The chemotherapy drugs and the radiation therapy used in this clinical trial are already approved for treatment of pancreas cancer. This trial is intended to establish which treatment is best for a specific patient, based on test results from that patient's actual adenocarcinoma. In the past, the decision as to which treatment the patient will receive was not based on testing of the actual adenocarcinoma. See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm. Hypothesis: Resectability rate, overall survival rate and progression-free survival in subjects with adenocarcinoma of the pancreas will be superior for who receive targeted "personalized" therapy.

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

Number of Subjects Completing Therapy Including Surgical Resection. [At time of surgery (approximately 10 to 20 weeks after screening)]. Count Of Participants, Participants. Milestones Related to Usual Therapy (n=130): 107.

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

Overall Survival in Months [5 years]. Median, Months (Full Range). Milestones Related to Therapy (Resected) (n=107): 45 (24 to 60); Milestones Related to Therapy (Non-Resected) (n=23): 11 (8 to 20).

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

Progression-free Survival [5 years]. Count Of Participants, Participants. Milestones Related to Usual Therapy (n=130): 36.

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

Use of Biomarkers to Determine Course of Treatment [Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)]. Count Of Participants, Participants. Milestones Related to Usual Therapy (n=130): 92.

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

Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors. [At time of surgery (approximately 10 to 20 weeks after screening)]. Count Of Participants, Participants. Complete Response: Milestones Related to Usual Therapy (n=107): 2. Near Complete Response: Milestones Related to Usual Therapy (n=107): 17. Partial Response: Milestones Related to Usual Therapy (n=107): 44. Poor or No Response: Milestones Related to Usual Therapy (n=107): 42. Results Not Available: Milestones Related to Usual Therapy (n=107): 2.