Pancreatic CancerPhase 2PANCNCT03322995
Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial
A Phase 2 study testing First-line Chemotherapy, Second-line Chemotherapy and Chemoradiation in people with Pancreatic Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- First-line Chemotherapy, Second-line Chemotherapy and Chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2018to 1 Jun 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older.
- Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
- 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; additional biopsy is not required for the study.
- 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:
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- total leukocytes >3 x10^3/μL.
- absolute neutrophil count (ANC) >1.5x 10^3/μL.
- hemoglobin >9 g/dL.
- platelets >100 x 10^3/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 principal investigators.
- 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.
Who cannot join
- Has received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy.
- No documentation of a CA19-9 value when total bilirubin < 2 prior to initiation of chemotherapy.
- Has received any additional 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 human immunodeficiency virus (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Froedtert & the Medical College of Wisconsin Clinical Cancer Center, 414-805-8900, cccto@mcw.edu
Kathleen Christians, MD
About this study
Official title: Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer
This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.
Read the detailed description
Patients will receive standard chemotherapy and chemoradiation for pancreatic cancer. The study intervention is an adaptive approach which modifies systemic therapy based on clinical assessments of treatment response. Treatment response will be assessed by imaging (CT scan), biomarker [serum cancer antigen (CA)19-9] and performance status assessment [short physical performance battery (SPPB) and Center for Epidemiologic Studies Depression Scale (CES-D) evaluations] at the first restaging assessment.
Treatment response will be categorized as:
- response;
- stable disease;
- local disease progression;
- metastatic disease progression.
After the first restaging evaluation, patients who demonstrate:
- a response will be maintained on the same chemotherapy;
- stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy;
- local progression will receive chemoradiation;
- metastatic disease will be removed from the trial.
Patients who complete four months of chemotherapy, will be treated with chemoradiation (50.4 Gray (Gy) in 28 fractions). In the absence of local disease progression deemed inoperable, or metastatic disease progression, patients will be offered surgical resection. Patients who did not receive four months of systemic therapy in the neoadjuvant setting will be offered four months of adjuvant therapy at the discretion of their treating physicians.
- Conditions
- Pancreatic Cancer
- Being tested
- First-line Chemotherapy, Second-line Chemotherapy, Chemoradiation
- Keywords
- Neoadjuvant, pancreatic adenocarcinoma, pancreas cancer, pancreatic cancer, molecular profiling, CA19-9, surgery, MCW
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-line ChemotherapyDrug
Also called Fluorouracil, Folinic acid, Camptosar, Eloxatin
The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.
Second-line ChemotherapyDrug
Also called Gemzar
Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.
ChemoradiationRadiation
50.4 Gy in 28 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Restaging: Response to Treatment | Experimental | 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. Receives: Drug: First-line Chemotherapy |
| Restaging: Patients with Stable Disease | Experimental | 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. Receives: Drug: Second-line Chemotherapy |
| Restaging: Local Disease Progression | Experimental | After the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, 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. Receives: Radiation: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of all intended neoadjuvant therapy and surgical therapy
This measure is the number of subjects completing all intended neoadjuvant therapy and surgical therapy.
Measured: Five years.
Secondary outcomes (2)
Overall survival
This measure is the number of subjects alive at the conclusion of the follow-up period.
Measured: Five years
Progression-free survival
This measure is the number of subjects achieving complete response, partial response or maintaining stable disease.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start21 Jun 2018
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Christians, Medical College of Wisconsin
- Investigators
- Kathleen Christians, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322995
- Sponsor's protocol ID
- PRO00030656
- Acronym
- PANC
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2017
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03322995
- Acronym / sponsor ID
- PANC / PRO00030656
- Conditions
- Pancreatic Cancer
- Keywords
- Neoadjuvant, pancreatic adenocarcinoma, pancreas cancer, pancreatic cancer, molecular profiling, CA19-9, surgery, MCW
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.
Detailed description
Patients will receive standard chemotherapy and chemoradiation for pancreatic cancer. The study intervention is an adaptive approach which modifies systemic therapy based on clinical assessments of treatment response. Treatment response will be assessed by imaging (CT scan), biomarker [serum cancer antigen (CA)19-9] and performance status assessment [short physical performance battery (SPPB) and Center for Epidemiologic Studies Depression Scale (CES-D) evaluations] at the first restaging assessment.
Treatment response will be categorized as:
- response;
- stable disease;
- local disease progression;
- metastatic disease progression.
After the first restaging evaluation, patients who demonstrate:
- a response will be maintained on the same chemotherapy;
- stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy;
- local progression will receive chemoradiation;
- metastatic disease will be removed from the trial.
Patients who complete four months of chemotherapy, will be treated with chemoradiation (50.4 Gray (Gy) in 28 fractions). In the absence of local disease progression deemed inoperable, or metastatic disease progression, patients will be offered surgical resection. Patients who did not receive four months of systemic therapy in the neoadjuvant setting will be offered four months of adjuvant therapy at the discretion of their treating physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Restaging: Response to Treatment | Experimental | Drug: First-line ChemotherapyAfter 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. |
| Restaging: Patients with Stable Disease | Experimental | Drug: Second-line ChemotherapyPatients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months. |
| Restaging: Local Disease Progression | Experimental | Radiation: ChemoradiationAfter the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be 18 years of age or older.
- Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
- 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; additional biopsy is not required for the study.
- Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
Key exclusion criteria (7 listed)
- Has received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy.
- No documentation of a CA19-9 value when total bilirubin < 2 prior to initiation of chemotherapy.
- Has received any additional 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First-line ChemotherapyAlso: Fluorouracil, Folinic acid, Camptosar, EloxatinThe first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care. | Drug | Restaging: Response to Treatment |
| Second-line ChemotherapyAlso: GemzarSecond line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician. | Drug | Restaging: Patients with Stable Disease |
| Chemoradiation50.4 Gy in 28 fractions. | Radiation | Restaging: Local Disease Progression |
Primary outcome
Completion of all intended neoadjuvant therapy and surgical therapy
Time frame: Five years.
This measure is the number of subjects completing all intended neoadjuvant therapy and surgical therapy.
2 secondary outcomes
Overall survival
Time frame: Five years
Progression-free survival
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Christians, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing First-line Chemotherapy, Second-line Chemotherapy and Chemoradiation in people with Pancreatic Cancer, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical College of Wisconsin Clinical Cancer Center (414-805-8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of all intended neoadjuvant therapy and surgical therapy (time frame: Five years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.