- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683315
PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples (PANCREAS)
October 15, 2023 updated by: Kathleen Christians, Medical College of Wisconsin
This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The study intervention involves molecular profiling Purity Independent Subtyping of Tumors (PurIST) subtyping of pretreatment Endoscopic Ultrasound Fine Needle Aspiration (EUS/FNA) samples to determine pancreatic cancer subtype.
Neoadjuvant therapy is directed based on the molecular subtype (classical vs. basal).
Patients with classical subtype will receive a standard chemotherapy (mFOLFIRINOX) and patients with basal subtype will receive an alternative standard therapy (gemcitabine/nab-paclitaxel).
Study Type
Interventional
Enrollment (Estimated)
87
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Medical College of Wisconsin Cancer Center Clinical Trials Office
- Phone Number: 8900 866-680-0505
- Email: cccto@mcw.edu
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258-4566
- Recruiting
- HonorHealth Medical Group
-
Contact:
- Erkut Borazanci, MD
- Phone Number: 480-323-1350
- Email: eborazanci@honorhealth.com
-
Contact:
- Gayle Jameson, APNP
- Phone Number: 480-323-1350
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Froedtert & the Medical College of Wisconsin
-
Contact:
- Kathleen Christians, MD
- Phone Number: 414-955-1400
- Email: kchristi@mcw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria (for Screening)
- Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy. Agrees to additional EUS biopsy to be performed at the first-restaging timepoint and tissue collection from surgical specimen.
- Have a carbohydrate antigen 19-9 (CA19-9) level greater than 35 mg/dL regardless of total bilirubin level.
Inclusion Criteria (for Treatment)
- Be 18 years of age or older.
- Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
- Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment Have an Eastern Cooperative Group (ECOG) performance status < 2 (please see the appendix).
- Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment.
- Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
Have adequate organ and bone marrow function, as defined by
- total leukocytes >3 x103/μL.
- absolute neutrophil count (ANC) >1.5x 103/μL.
- hemoglobin >9 g/dL.
- platelets >100 x 10e3/μL.
- creatinine clearance >60 mL/min or creatinine <1.5 mg/dL.
- bilirubin < 2 mg/dL.
- aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) <3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST/ALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial PIs.
- Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 > 35 U/mL, when total bilirubin <2 mg/dL
- Female patients must be postmenopausal (absence of menses for > 1 year), surgically sterile or have a negative pregnancy test and use at least one form of contraception for four weeks prior to Day 1 of the study, during study treatment and during the first four months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for four months after the last dose of any study drug.
Exclusion Criteria:
- Has received chemotherapy and/or radiation within three years prior to study enrollment.
- Has 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 or localized prostate cancer with normal prostate specific antigen) within three 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 (BMI >55) or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
- Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subtype diagnosis and classification: Basal
Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer.
Upon diagnosis, patients categorized as basal will receive two months of the Gemcitabine/Nab-paclitaxel Treatment Regimen.
|
This regimen will be nab-paclitaxel and gemcitabine.
Other Names:
|
Experimental: Subtype diagnosis and classification: Classical
Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer.
Patients in the classical group will receive two months of the mFOLFIRINOX Treatment Regimen.
|
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
Other Names:
|
Experimental: Basal Group: Restaging: Response to Treatment
After the first restaging evaluation, further treatment will be based on treatment response.
Patients who demonstrate a response [decline in carbohydrate antigen 19-9 (CA19-9) values] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months.
|
This regimen will be nab-paclitaxel and gemcitabine.
Other Names:
|
Experimental: Classical Group: Restaging: Response to Treatment
After the first restaging evaluation, further treatment will be based on treatment response.
Patients who demonstrate a response [decline in carbohydrate antigen 19-9 (CA19-9) values] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months.
|
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
Other Names:
|
Experimental: Basal Group: Restaging: Patients with Stable Disease
Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.
|
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
Other Names:
|
Experimental: Classical Group: Restaging: Patients with Stable Disease
Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.
|
This regimen will be nab-paclitaxel and gemcitabine.
Other Names:
|
Experimental: Basal Group: Restaging: Local Disease Progression
Further treatment will be based on treatment response.
If the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.
|
50.4 Gy in 28 fractions.
|
Experimental: Classical Group: Restaging: Local Disease Progression
Further treatment will be based on treatment response.
If the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.
|
50.4 Gy in 28 fractions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects who receive PurIST classification-directed therapy.
Time Frame: 12 weeks
|
The number of subjects who receive PurIST classification-directed therapy and have a treatment response following 12 weeks of therapy.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects with basal subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.
Time Frame: One year
|
The number of subjects completing all intended neoadjuvant therapy and surgical therapy.
|
One year
|
Subjects with classical subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.
Time Frame: One year
|
The number of subjects completing all intended neoadjuvant therapy and surgical therapy.
|
One year
|
Treatment response for subjects with basal subtype tumors.
Time Frame: 12 weeks
|
The number of subjects with basal subtype tumors who have a treatment response.
|
12 weeks
|
Treatment response for subjects with classical subtype tumors.
Time Frame: 12 weeks
|
The number of subjects with classical subtype tumors who have a treatment response.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathleen K Christians, MD, Medical College of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
December 19, 2020
First Submitted That Met QC Criteria
December 19, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 15, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Fluorouracil
- Gemcitabine
Other Study ID Numbers
- PRO00039451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Cancer
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of NebraskaNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic Cancer | Stage I Pancreatic Cancer | Resectable Pancreatic Carcinoma | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Recurrent Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of Wisconsin, MadisonCompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Fudan UniversityUnknownStage ⅠA Pancreatic Cancer | Stage ⅠB Pancreatic Cancer | Stage ⅡA Pancreatic Cancer | Stage ⅡB Pancreatic CancerChina
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
Shanghai Zhongshan HospitalFudan UniversityNot yet recruitingPancreatic Cancer Stage III | Pancreatic Cancer, Stage IB | Pancreatic Cancer, Stage IIA | Pancreatic Cancer, Stage IIBChina
Clinical Trials on Chemoradiation
-
Muriel POUBLANCWithdrawnOverall Survival Comparison Between the 2 Arms
-
University of California, San FranciscoTerminatedRectal AdenocarcinomaUnited States
-
Chinese University of Hong KongCompleted
-
Chongqing University Cancer HospitalZhejiang Cancer Hospital; Sun Yat-sen University; Fujian Cancer Hospital; Tongji... and other collaboratorsRecruitingCervical CancerChina
-
University Medical Center GroningenRecruitingEsophageal CancerNetherlands
-
University Medical Center GroningenRecruiting
-
Mackay Memorial HospitalCompleted
-
Institut de Cancérologie de LorraineCompleted
-
Azienda Ospedaliera SS. Antonio e Biagio e Cesare...Recruiting
-
Centre hospitalier de l'Université de Montréal...M.D. Anderson Cancer Center; Lawson Health Research Institute; Jewish General...RecruitingHead and Neck Cancer | Oropharynx Cancer | Human Papilloma VirusCanada