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Clinical Trial Record

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Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

2018-06-21

2026-08-01

2027-08-01

125

Study Overview

Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.

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: 1. response; 2. stable disease; 3. local disease progression; 4. metastatic disease progression. After the first restaging evaluation, patients who demonstrate: 1. a response will be maintained on the same chemotherapy; 2. stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy; 3. local progression will receive chemoradiation; 4. 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.

  • Pancreatic Cancer
  • DRUG: First-line Chemotherapy
  • DRUG: Second-line Chemotherapy
  • RADIATION: Chemoradiation
  • PRO00030656

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 Registration Dates Results Reporting Dates Study Record Updates

2017-10-24  

N/A  

2024-11-19  

2017-10-24  

N/A  

2024-11-21  

2017-10-26  

N/A  

2024-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: 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) wil

DRUG: First-line Chemotherapy

  • The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.
EXPERIMENTAL: 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.

DRUG: Second-line Chemotherapy

  • 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.
EXPERIMENTAL: Restaging: Local Disease Progression

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 continu

RADIATION: Chemoradiation

  • 50.4 Gy in 28 fractions.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Completion of all intended neoadjuvant therapy and surgical therapyThis measure is the number of subjects completing all intended neoadjuvant therapy and surgical therapy.Five years.
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Overall survivalThis measure is the number of subjects alive at the conclusion of the follow-up period.Five years
Progression-free survivalThis measure is the number of subjects achieving complete response, partial response or maintaining stable disease.Five years

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 Clinical Cancer Center

Phone Number: 414-805-8900

Email: cccto@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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    INCLUSION CRITERIA

  • 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:


  • 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.

    • EXCLUSION CRITERIA

  • 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Kathleen Christians, MD, Professor

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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