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
3 other identifiers
interventional
229
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2011
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 28, 2011
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2022
CompletedResults Posted
Study results publicly available
August 14, 2023
CompletedAugust 14, 2023
July 1, 2023
6.6 years
December 28, 2011
May 22, 2023
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At time of surgery (approximately 10 to 20 weeks after screening)
Secondary Outcomes (4)
Overall Survival in Months
5 years
Progression-free Survival
5 years
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)
Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.
At time of surgery (approximately 10 to 20 weeks after screening)
Study Arms (1)
Milestones related to therapy
EXPERIMENTALMilestone 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age or older
- 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
- +14 more criteria
You may not qualify if:
- Any patient with one or more of the following will be excluded:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- University of Cincinnaticollaborator
Study Sites (2)
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45221, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
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.
PMID: 20180029BACKGROUNDTsai 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.
PMID: 30080723RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan Tsai, MD
- Organization
- Froedtert and the Medical College of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas B. Evans, M.D., FACS
Medical College of Wisconsin
- PRINCIPAL INVESTIGATOR
Kathleen Christians, M.D., FACS
Medical College of Wisconsin
- PRINCIPAL INVESTIGATOR
Susan Tsai, M.D., M.H.S.
Medical College of Wisconsin
- PRINCIPAL INVESTIGATOR
Paul Ritch, M.D.
Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2011
First Posted
November 15, 2012
Study Start
November 1, 2011
Primary Completion
June 1, 2018
Study Completion
April 11, 2022
Last Updated
August 14, 2023
Results First Posted
August 14, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share