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Anti-metabolites
Adaptive Neoadjuvant Chemotherapy for Pancreatic Cancer (PANCREAS Trial)
Phase 2
Recruiting
Led By Susan Tsai, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
PANCREAS Trial Summary
This trial is testing a new cancer treatment in patients with resectable or borderline resectable pancreatic cancer.
Who is the study for?
This trial is for adults with resectable or borderline resectable pancreatic cancer. Participants must have confirmed adenocarcinoma, an ECOG performance status less than 2 (meaning they are able to carry out all self-care but unable to carry out any work activities), and adequate organ/bone marrow function. They need a CA19-9 level above 35 mg/dL and must understand the study well enough to give informed consent.Check my eligibility
What is being tested?
The study tests two chemotherapy regimens: mFOLFIRINOX and Gemcitabine/Nab-paclitaxel, along with chemoradiation in patients with operable pancreatic cancer. It's a phase II trial where doctors will adapt treatment based on RNA expression profiles from biopsy samples taken through endoscopic ultrasound (EUS).See study design
What are the potential side effects?
Common side effects of these treatments may include nausea, vomiting, diarrhea, fatigue, decreased blood cell counts leading to increased infection risk or bleeding problems, hair loss, and potential nerve damage that can cause pain or numbness.
PANCREAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as adenocarcinoma and I can do most daily activities.
Select...
My pancreatic cancer is at a stage where surgery might be possible.
Select...
I am 18 years old or older.
PANCREAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjects who receive PurIST classification-directed therapy.
Secondary outcome measures
Subjects with basal subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.
Subjects with classical subtype tumors who complete all intended neoadjuvant therapy and surgical therapy.
Treatment response for subjects with basal subtype tumors.
+1 morePANCREAS Trial Design
8Treatment groups
Experimental Treatment
Group I: Subtype diagnosis and classification: ClassicalExperimental Treatment1 Intervention
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.
Group II: Subtype diagnosis and classification: BasalExperimental Treatment1 Intervention
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.
Group III: Classical Group: Restaging: Response to TreatmentExperimental Treatment1 Intervention
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.
Group IV: Classical Group: Restaging: Patients with Stable DiseaseExperimental Treatment1 Intervention
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.
Group V: Classical Group: Restaging: Local Disease ProgressionExperimental Treatment1 Intervention
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.
Group VI: Basal Group: Restaging: Response to TreatmentExperimental Treatment1 Intervention
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.
Group VII: Basal Group: Restaging: Patients with Stable DiseaseExperimental Treatment1 Intervention
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.
Group VIII: Basal Group: Restaging: Local Disease ProgressionExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemoradiation
2006
Completed Phase 3
~990
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,496 Total Patients Enrolled
Susan Tsai, MDPrincipal Investigator - Medical College of Wisconsin
Clement J. Zablocki VA Medical Center, Froedtert & The Medical College of Wisconsin
University Of Michigan Medical Sch (Medical School)
University Of Mi Hosps (Residency)
Kathleen K Christians, MDPrincipal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are functioning well.My cancer diagnosis was confirmed through a biopsy.I am suspected to have pancreatic cancer and agree to additional biopsies.My cancer is confirmed as adenocarcinoma and I can do most daily activities.Your CA19-9 level is higher than 35 mg/dL, regardless of your total bilirubin level.My pancreatic cancer is at a stage where surgery might be possible.Requirements for being eligible to participate in the initial screening process.Requirements for being eligible to participate in the treatment.You can read and sign a document stating that you agree to participate in the study, or you have someone who is legally authorized to sign for you.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Classical Group: Restaging: Patients with Stable Disease
- Group 2: Basal Group: Restaging: Local Disease Progression
- Group 3: Basal Group: Restaging: Response to Treatment
- Group 4: Classical Group: Restaging: Local Disease Progression
- Group 5: Subtype diagnosis and classification: Basal
- Group 6: Subtype diagnosis and classification: Classical
- Group 7: Classical Group: Restaging: Response to Treatment
- Group 8: Basal Group: Restaging: Patients with Stable Disease
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Chemoradiation a secure treatment option for individuals?
"Chemoradiation's safety was assessed and rated a 2, as there is evidence of its security in clinical trials but efficacy has yet to be evaluated."
Answered by AI
Are there any prior studies on the efficacy of Chemoradiation?
"As of now, 1621 Chemoradiation studies are ongoing with 480 in Phase 3. Most clinical trials for this therapy run out of Guangzhou, Guangdong however there is a total 81368 sites running relevant research."
Answered by AI
Is there currently a call for volunteers to join this research experiment?
"Affirmative. The information available from clinicaltrials.gov marks this medical trial as actively recruiting, with an initial posting on April 1st 2021 and a recent update on July 29th 2022. At present, 41 patients must be enrolled at two distinct sites."
Answered by AI
What is the upper limit of participants in this medical experiment?
"Affirmative. The information found on clinicaltrials.gov conveys that this medical experiment has opened its recruitment process, which was first launched in April 2021 and most recently updated at the end of July 2022. A total of 41 patients will be recruited from two distinct sites."
Answered by AI
What maladies can be ameliorated by combining chemotherapy and radiation?
"Chemoradiation is a popular treatment for malignant tumours, but can also be employed to treat conditions such as non-small cell lung carcinoma, rectal carcinoma and colorectal carcinoma."
Answered by AI
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