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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
229
The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
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).
The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
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).
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.
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).
The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
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).
Chemotherapy treatment with Gemcitabine.
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).
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).
The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
Chemotherapy treatment with Gemcitabine.
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.
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Number of Subjects Completing Therapy Including Surgical Resection.
This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.
Time frame: At time of surgery (approximately 10 to 20 weeks after screening)
Overall Survival in Months
This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.
Time frame: 5 years
Progression-free Survival
This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.
Time frame: 5 years
Use of Biomarkers to Determine Course of Treatment
The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.
Time frame: Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)
Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.
The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response).
Time frame: At time of surgery (approximately 10 to 20 weeks after screening)
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