NCT01726582

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

A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Milestone 1: Targeted chemotherapy prior to surgery	The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
RADIATION	Milestone 2: Chemoradiotherapy (cXRT)	A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or intensity-modulated radiation therapy (IMRT) techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
DRUG	Milestone 3: Targeted chemotherapy prior to surgery	The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
RADIATION	Milestone 3: Chemoradiotherapy (cXRT)	A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
DRUG	Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery	A biopsy of the borderline tumor does not provide a molecular profile that can be used to target treatment. The treatment will be standard FOLFIRINOX chemotherapy regimen.
RADIATION	Milestone 4: Chemoradiotherapy (cXRT)	A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
DRUG	Milestone 5: Targeted chemotherapy after surgery	The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
RADIATION	Milestone 5: Chemoradiotherapy (cXRT)	A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
DRUG	Milestone 6: Gemcitabine after surgery	Chemotherapy treatment with Gemcitabine.
RADIATION	Milestone 6: Chemoradiotherapy (cXRT)	A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
RADIATION	Milestone 7: Chemoradiotherapy (cXRT)	A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
DRUG	Milestone 8: Targeted chemotherapy after surgery	The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
DRUG	Milestone 9: Gemcitabine after surgery	Chemotherapy treatment with Gemcitabine.
OTHER	Milestone 10: No additional therapy after surgery	The molecular profile of the tumor that was removed during surgery points to a lack of treatment affect for available therapies. No additional therapy is recommended.

Timeline

• Start date: 2011-11-01
• Primary completion: 2018-06-01
• Completion: 2022-04-11
• First posted: 2012-11-15
• Last updated: 2023-08-14
• Results posted: 2023-08-14

Locations

2 sites across 1 country: United States