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Vitamin B9

Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.

Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.

Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.

Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.

Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.

Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.

Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.

The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.

Milestone 1: Targeted chemotherapy prior to surgery

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).

Milestone 2: Chemoradiotherapy (cXRT)

Milestone 3: Targeted chemotherapy prior to surgery

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).

Milestone 3: Chemoradiotherapy (cXRT)

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.

Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery

Milestone 4: Chemoradiotherapy (cXRT)

The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.

Milestone 5: Targeted chemotherapy after surgery

Milestone 5: Chemoradiotherapy (cXRT)

Milestone 6: Gemcitabine after surgery

Milestone 6: Chemoradiotherapy (cXRT)

Milestone 7: Chemoradiotherapy (cXRT)

Milestone 8: Targeted chemotherapy after surgery

Milestone 9: Gemcitabine 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.

Milestone 10: No additional therapy after surgery

Douglas B. Evans, M.D., FACS

Kathleen Christians, M.D., FACS

Susan Tsai, M.D., M.H.S.

Paul Ritch, M.D.

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.

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

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.

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.

This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.

The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.

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).

University of Cincinnati

Medical College of Wisconsin

Professor

The treatment milestones are represent the usual care for this condition. Only serious adverse events were collected.

Milestones Related to Therapy

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Susan Tsai, MD

Milestones Related to Usual Therapy

Number of Subjects Completing Therapy Including Surgical Resection.

This population includes the participants who were eligible for and completed surgical resection of residual tumor. Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.

Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.

Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.

Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.

Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.

Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.

Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.

Milestones Related to Therapy (Resected)

This population includes participants for whom surgical resection was contraindicated and did not occur.

Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.

Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.

Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.

Milestones Related to Therapy (Non-Resected)

Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.

Overall Survival in Months

Progression-free Survival

Use of Biomarkers to Determine Course of Treatment

Pathology results were not reported for two subject.

Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.

The milestones described below represent the treatment progression patients follow for treatment of this disease. The milestone represents changes in therapy based on medical condition and are not intended to represent discrete events in the investigation. Study are not parsed for analysis among the treatment milestones.

Milestone 1: Targeted chemotherapy prior to surgery: 8 weeks targeted chemotherapy; restaging.

Milestone 2: Before surgery: Chemoradiotherapy (cRXT); restaging Milestone 3: Before surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.

Milestone 4: standard FOLFIRINOX chemotherapy prior to surgery: 8 weeks FOLFIRINOX (standard chemotherapy); restaging; standard chemoradiotherapy (cXRT); restaging.

Milestone 5: After surgery: 8 weeks targeted chemotherapy; restaging; chemoradiotherapy (cXRT); restaging.

Milestone 6: Gemcitabine after surgery: 8 weeks standard Gemcitabine (chemotherapy); restaging; chemoradiotherapy (cXRT); restaging.

Milestone 7: After surgery: chemoradiotherapy (cXRT); restaging. Milestone 8: Gemcitabine after surgery: 8 weeks Gemcitabine (chemotherapy); restaging; 8 weeks Gemcitabine (chemotherapy); restaging.

Milestone 9: No additional therapy after surgery. Milestone 10: After surgery no additional treatment.

Milestones Related to Standard Therapy

Overall Study

Spots Global Cancer Trial Database for milestone 8: targeted chemotherapy after surgery