Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery ("Personalized Medicine")
NCT ID: NCT01726582
Last Updated: 2023-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
229 participants
INTERVENTIONAL
2011-11-30
2022-04-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Milestones related to therapy
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.
Milestone 1: Targeted chemotherapy prior to surgery
The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
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).
Milestone 3: Targeted chemotherapy prior to surgery
The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
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).
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.
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).
Milestone 5: Targeted chemotherapy after surgery
The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
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).
Milestone 6: Gemcitabine after surgery
Chemotherapy treatment with Gemcitabine.
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).
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).
Milestone 8: Targeted chemotherapy after surgery
The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
Milestone 9: Gemcitabine after surgery
Chemotherapy treatment with Gemcitabine.
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.
Interventions
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Milestone 1: Targeted chemotherapy prior to surgery
The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
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).
Milestone 3: Targeted chemotherapy prior to surgery
The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
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).
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.
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).
Milestone 5: Targeted chemotherapy after surgery
The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
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).
Milestone 6: Gemcitabine after surgery
Chemotherapy treatment with Gemcitabine.
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).
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).
Milestone 8: Targeted chemotherapy after surgery
The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
Milestone 9: Gemcitabine after surgery
Chemotherapy treatment with Gemcitabine.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to understand and provide written informed consent
* Diagnosis of adenocarcinoma of the pancreas or high suspicion of adenocarcinoma of the pancreas based on CT and MRI findings as detailed below by "Definition of...."
Treatment Eligibility Criteria:
* Have an Eastern Cooperative Oncology Group performance status less than or equal to 2
* Have biopsy-proven resectable or borderline resectable adenocarcinoma of the pancreas
* Have adequate organ and bone marrow function as defined by:
* total leukocytes greater than or equal to 3 x1000/μL
* absolute neutrophil count (ANC) \> or equal to 1.5x 1000/μL
* hemoglobin \> or equal to 9 g/dL
* platelets \> or equal to 100 x 1000/μL
* creatinine clearance \>60 mL/min or creatinine \< or equal to 1.5 mg/dL
* bilirubin \< or equal to 2 mg/dL or \>2 and declining as described in the protocol
* aspartate transaminases (AST/SGOT) \< or equal to3 x upper limit of normal (ULN)
* alanine transaminases (ALT/SGPT) \< or equal to 3 x ULN
* Female patients must be post menopausal for \> 1 year, surgically sterile, or have a negative pregnancy test and used at least one form of contraception for 4 weeks prior to Day 1 of the study, during study treatment and during the first 4 months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for 4 months after the last dose of any study drug.
Definition of Resectable Pancreatic Cancer includes:
* No evidence of extra-pancreatic disease
* No evidence of tumor-arterial abutment (celiac, superior mesenteric artery or hepatic artery)
* If tumor induced narrowing of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence is present it must be \<50% of the diameter of the vessel
* Ca19-9 \<5000, when bilirubin is \<2 (or \>2 and declining as described in the protocol)
Definition of Borderline Resectable Pancreatic Cancer to include at least one of the following:
* Tumor abutment \< or equal to 180 degrees of the superior mesenteric artery or celiac axis
* Tumor abutment or encasement (\>180 degrees) of a short segment of the hepatic artery
* Tumor induced narrowing of superior mesenteric vein, portal vein or superior mesenteric-portal vein of \>50% of the diameter of the vessel.
* Short segment occlusion of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence with a suitable portal vein above and superior mesenteric vein below, for reconstruction
* CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on multidisciplinary assessment at the Medical College of Wisconsin weekly pancreatic cancer conference)
* Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound-guided fine needle aspirate
* Resectable tumor and cancer antigen 19-9 (CA19-9) \>5000
Exclusion Criteria
* Have received chemotherapy or chemoradiation within 5 years prior of study enrollment
* Have any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study enrollment
* Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
* Known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection
* Pregnant or breast-feeding patients or any patient with child-bearing potential not using contraception 4 weeks prior to, during and 4 months after study treatment is discontinued
18 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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Susan Tsai
Professor
Principal Investigators
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Douglas B. Evans, M.D., FACS
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Kathleen Christians, M.D., FACS
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Susan Tsai, M.D., M.H.S.
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Paul Ritch, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.
Tsai S, Christians KK, George B, Ritch PS, Dua K, Khan A, Mackinnon AC, Tolat P, Ahmad SA, Hall WA, Erickson BA, Evans DB. A Phase II Clinical Trial of Molecular Profiled Neoadjuvant Therapy for Localized Pancreatic Ductal Adenocarcinoma. Ann Surg. 2018 Oct;268(4):610-619. doi: 10.1097/SLA.0000000000002957.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Advancing a Healthier WI
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FP 7718
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MCW 15565
Identifier Type: -
Identifier Source: org_study_id
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