Borderline Resectable Pancreatic AdenocarcinomaPhase 2NCT04481204
New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study
A Phase 2 study testing Cisplatin, Fluorouracil and Gemcitabine in people with Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma, run by M.D. Anderson Cancer Center.
Trial summary
This is a phase II study using the Bayesian platform design. There are three clinical stage groups of localized pancreatic cancer: resectable, borderline resectable, and locally advanced disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Cisplatin, Fluorouracil and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2023to 27 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Confirmation of clinical stage of resectable
- TREATMENT NAIVE RESECTABLE PDAC COHORT: No prior chemotherapy or radiation therapy for PDAC
- TREATMENT NAIVE RESECTABLE PDAC COHORT: No current use of immunosuppressive medication
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Not pregnant and not nursing, for women of childbearing potential, a negative urine or blood pregnancy test done =< 7 days prior to registration is required
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Life expectancy greater than 6 months
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- TREATMENT NAIVE RESECTABLE PDAC COHORT: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC) >= 1,500/mm^3
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Platelet count >= 100,000/mm^3
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Creatinine =< 1.5 x upper limit of normal (ULN)
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Calculated (Calc.) creatinine clearance > 45 mL/min
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Total bilirubin =< 2.0 mg/dL
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Hemoglobin >= 8.0 mg/dL
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Confirmation of clinical stage of resectable
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Prior chemotherapy for PDAC is allowed, as long as the regimen is considered a standard regimen for PDAC (e.g., gemcitabine, gemcitabine-cisplatin, gemcitabine/nab-paclitaxel, gemcitabine/capecitabine, FOLFIRINOX). This should be discussed with the study principal investigators (PIs) prior to enrollment to ensure the regimen for a given patient is acceptable
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: No current use of immunosuppressive medication
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Not pregnant and not nursing, For women of childbearing potential, a negative urine or blood pregnancy test done ≤ 7 days prior to registration is required
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Life expectancy greater than 6 months
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: ECOG performance status 0 or 1
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC) >= 1,500/mm^3
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Platelet count >= 100,000/mm^3
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Creatinine =< 1.5 x upper limit of normal (ULN)
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Calc. creatinine clearance > 45 mL/min
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Total bilirubin =< 2.0 mg/dL
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: AST/ALT =< 2.5 x upper limit of normal (ULN)
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Hemoglobin >= 8.0 mg/dL
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Confirmation of clinical stage of borderline resectable
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: No prior chemotherapy or radiation therapy for PDAC
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: No current use of immunosuppressive medication
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Not pregnant and not nursing, For women of childbearing potential, a negative urine or blood pregnancy test done ≤ 7 days prior to registration is required
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Life expectancy greater than 6 months
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: ECOG performance status 0 or 1
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC) >= 1,500/mm^3
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Platelet count >= 100,000/mm^3
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Creatinine =< 1.5 x upper limit of normal (ULN)
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Calc. creatinine clearance > 45 mL/min
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Total bilirubin =< 2.0 mg/dL
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: AST/ALT =< 2.5 x upper limit of normal (ULN)
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Hemoglobin >= 8.0 mg/dL
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Confirmation of clinical stage of borderline resectable
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Prior chemotherapy for PDAC is allowed, as long as the regimen is considered a standard regimen for PDAC (e.g., gemcitabine, gemcitabine-cisplatin, gemcitabine/nab-paclitaxel, gemcitabine/capecitabine, FOLFIRINOX). This should be discussed with the study PIs prior to enrollment to ensure the regimen for a given patient is acceptable
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: No current use of immunosuppressive medication
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Not pregnant and not nursing, For women of childbearing potential, a negative urine or blood pregnancy test done =< 7 days prior to registration is required
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Life expectancy greater than 6 months
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: ECOG performance status 0 or 1
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Absolute neutrophil count (ANC) >= 1,500/mm^3
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Platelet count >= 100,000/mm^3
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Creatinine =< 1.5 x upper limit of normal (ULN)
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Calc. creatinine clearance > 45 mL/min
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Total bilirubin =< 2.0 mg/dL
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: AST/ALT =< 2.5 x upper limit of normal (ULN)
- PREVIOUSLY TREATED BORDERLINE RESECTABLE PDAC COHORT: Hemoglobin >= 8.0 mg/dL
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Confirmation of clinical stage of locally advanced
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: No prior chemotherapy or radiation therapy for PDAC
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Pregnancy and Nursing Status: Not pregnant and not nursing, For women of childbearing potential, a negative urine or blood pregnancy test done ≤ 7 days prior to registration is required
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Life expectancy greater than 6 months
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: ECOG performance status 0 or 1
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Absolute neutrophil count (ANC) >= 1,500/mm^3
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Platelet count >= 100,000/mm^3
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Creatinine =< 1.5 x upper limit of normal (ULN)
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Calc. creatinine clearance > 45 mL/min
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Total bilirubin =< 2.0 mg/dL
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: AST/ALT =< 2.5 x upper limit of normal (ULN)
- TREATMENT NAIVE LOCALLY ADVANCED PDAC COHORT: Hemoglobin >= 8.0 mg/dL
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Confirmation of clinical stage of locally advanced
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Prior chemotherapy for PDAC is allowed, as long as the regimen is considered a standard regimen for PDAC (e.g., gemcitabine, gemcitabine-cisplatin, gemcitabine/nab-paclitaxel, gemcitabine/capecitabine, FOLFIRINOX). This should be discussed with the study PIs prior to enrollment to ensure the regimen for a given patient is acceptable
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: No current use of immunosuppressive medication
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Not pregnant and not nursing, For women of childbearing potential, a negative urine or blood pregnancy test done =< 7 days prior to registration is required
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Life expectancy greater than 6 months
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: ECOG performance status 0 or 1
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Absolute neutrophil count (ANC) >= 1,500/mm^3
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Platelet count >= 100,000/mm^3
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Creatinine =< 1.5 x upper limit of normal (ULN)
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Calc. creatinine clearance > 45 mL/min
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Total bilirubin =< 2.0 mg/dL
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: AST/ALT =< 2.5 x upper limit of normal (ULN)
- PREVIOUSLY TREATED LOCALLY ADVANCED PDAC COHORT: Hemoglobin >= 8.0 mg/dL
Who cannot join
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Previous treatment for PDAC with chemotherapy or radiation
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Active malignancy, except basal cell carcinoma
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Staging other than resectable PDAC
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Known uncontrolled (grade >=2) or active gastric or duodenal ulcer disease within 30 days of enrollment
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Prior surgical resection of pancreatic tumor
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast
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- TREATMENT NAIVE RESECTABLE PDAC COHORT: Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place)
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Class III or IV congestive heart failure as defined by the New York Heart Association functional classification system < 6 months prior to screening
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
- Patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Female patients who are pregnant of breastfeeding
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of < 1% per year when used consistently and correctly
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Have significant psychiatric, social, or medical condition(s) that could increase the subject's risk, interfere with protocol adherence, or affect the subject's ability to give informed consent
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: The patient is treatment naive
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: The patient previously received radiation to the abdomen for any reason
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Active malignancy, except basal cell carcinoma
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Staging other than resectable PDAC at the time of diagnosis
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Receiving any approved or investigational anti-neoplastic agent other than the chemotherapies specified in this protocol
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Known uncontrolled (grade >= 2) or active gastric or duodenal ulcer disease within 30 days of enrollment
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Prior surgical resection of pancreatic tumor
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Known contraindication to iodine-based or gadolinium-based IV contrast
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place)
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Class III or IV congestive heart failure as defined by the New York Heart Association functional classification system < 6 months prior to screening
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Known active, uncontrolled (high viral load) HIV, hepatitis B or hepatitis C infection
- Patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Female patients who are pregnant of breastfeeding
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of < 1% per year when used consistently and correctly
- PREVIOUSLY TREATED RESECTABLE PDAC COHORT: Have significant psychiatric, social, or medical condition(s) that could increase the subject's risk, interfere with protocol adherence, or affect the subject's ability to give informed consent
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Previous treatment for PDAC with chemotherapy or radiation
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Active malignancy, except basal cell carcinoma
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Staging other than borderline resectable PDAC
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Known uncontrolled (grade >= 2) or active gastric or duodenal ulcer disease within 30 days of enrollment
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Prior surgical resection of pancreatic tumor
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Known contraindication to iodine-based or gadolinium-based IV contrast
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place)
- TREATMENT NAIVE BORDERLINE RESECTABLE PDAC COHORT: Class III or IV congestive hea
About this study
Official title: PIONEER-Panc: Phase II Investigations of New and Emerging Therapies for Pancreatic Cancer
This is a phase II study using the Bayesian platform design. There are three clinical stage groups of localized pancreatic cancer: resectable, borderline resectable, and locally advanced disease. Each stage group will have a defined standard of care chemotherapy regimen for a control arm, serving as a basis of comparison. Each group may have one or more experimental arms. Experimental arms may be added to the platform over time, and the effects of the experimental treatments will be tested against the controls for each group.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate major pathological response rate. (Resectable and borderline resectable groups [treatment naive or previously treated]) II. To estimate 6-month disease control rate. (Locally advanced groups [treatment naive or previously treated])
SECONDARY OBJECTIVES:
- To measure progression free survival and overall survival. (Resectable and borderline resectable groups [treatment naive or previously treated]) II. To measure progression free survival and overall survival. (Locally advanced groups [treatment naive or previously treated])
EXPLORATORY OBJECTIVES:
- To benchmark tissue acquisition protocols for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) analysis in pancreatic ductal adenocarcinoma (PDAC).
II. To demonstrate concordance of cell free DNA detected mutations to those detected in the tumor-derived DNA in PDAC.
III. To demonstrate response through exosome and circulating tumor DNA. IV. To demonstrate response through the quantification of the immune activation by analyzing T and B cells, peripheral blood mononuclear cells, and tissue biopsies.
- To derive organoids from human PDAC and measure drug response in vitro. VI. To analyze the tumor microenvironment through immunohistochemistry (IHC) and hypoxia staining.
VII. To associate prognosis of patients with baseline and follow-up quantitative computed tomography (CT) image based analysis.
VIII. To associate clinical and pathological outcomes of patients with changes in radiomic measurements.
IX. To correlate quality of life for patients on standard and experimental therapies with laboratory, radiological, pathological, and clinical characteristics.
OUTLINE:Patients are assigned to different groups, and each group has a control arm. Within each group, the patient will be randomized to the appropriate control or an experimental arm. The control arms for the groups are:
Control arm for Group I (Treatment-naive resectable PDAC): Patients receive fluorouracil, irinotecan, leucovorin, and oxaliplatin (mFOLFIRINOX) for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity.
Control arm for Group II (Previously-treated resectable PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for up to 4 months in the absence of disease progression or unacceptable toxicity.
Control arm for Group III (Treatment-naive borderline resectable PDAC): Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
Control arm for Group IV (Previously-treated borderline resectable PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
Control arm for Group V (Treatment-naive locally advanced PDAC): Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
Control arm for Group VI (Previously-treated locally advanced PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
After completion of study treatment, patients are followed up every 16 weeks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given IV
GemcitabineDrug
Also called dFdC, dFdCyd, Difluorodeoxycytidine
Given IV
IrinotecanDrug
Given IV
LeucovorinDrug
Also called Folinic acid
Given IV
Nab-paclitaxelDrug
Also called ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel
Given IV
OxaliplatinDrug
Also called 1-OHP, Ai Heng, Aiheng, Dacotin
Given IV
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo RT
| Study group | Role | What they receive |
|---|---|---|
| Control arm GroupI(mFOLFIRINOX) | Active comparator | Patients receive mFOLFIRINOX for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity. Receives: Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin; Drug: Oxaliplatin |
| Control arm GroupII(chemotherapy, FOLFIRINOX) | Active comparator | Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for up to 4 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cisplatin; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: Nab-paclitaxel; Drug: Oxaliplatin |
| Control arm GroupIII(FOLFIRINOX, radiation therapy) | Active comparator | Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors. Receives: Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin; Drug: Oxaliplatin; Radiation: Radiation Therapy |
| Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy) | Active comparator | Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors. Receives: Drug: Cisplatin; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Radiation: Radiation Therapy |
| Control arm GroupV(FOLFIRINOX, radiation therapy) | Active comparator | Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors Receives: Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin; Drug: Oxaliplatin; Radiation: Radiation Therapy |
| Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) | Active comparator | Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors Receives: Drug: Cisplatin; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate
Major pathological response is any patient who has grade I or II treatment response. Grade I - 0% residual tumor cells in the specimen (pathologic complete response, grade II - 1 to < 5% residual tumor cells in the specimen.
Measured: 12 weeks
Disease control rate
Measured as the proportion of patients without progression.
Measured: 6 months
Secondary outcomes (2)
Progression free survival
Will be estimated using the Kaplan-Meier method. Comparisons of these time-to-event endpoints by important covariate subgroups will be made using the log-rank tests. Cox proportional hazards regression models will be explored to evaluate the associations between the time-to-event endpoints and covariates of interest.
Measured: From the date of treatment initiation to the date of disease progression, recurrence after surgery or death from any cause whichever occurs first, assessed up to 5 years
Overall survival
Will be estimated using the Kaplan-Meier method. Comparisons of these time-to-event endpoints by important covariate subgroups will be made using the log-rank tests. Cox proportional hazards regression models will be explored to evaluate the associations between the time-to-event endpoints and covariates of interest.
Measured: From treatment start till death or last follow-up if the patient is alive, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start18 Apr 2023
- Primary completion27 Apr 2026
- Study completion27 Apr 2026
Why it stopped: 0 participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eugene J Koay, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481204
- Sponsor's protocol ID
- 2020-0075
- Other IDs
- NCI-2020-04886, 2020-0075
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Douglas JE, Liu S, Ma J, Wolff RA, Pant S, Maitra A, Tamm EP, Bhosale P, Katz MHG, Varadhachary GR, Koay EJ. PIONEER-Panc: a platform trial for phase II randomized investigations of new and emerging therapies for localized pancreatic cancer. BMC Cancer. 2022 Jan 3;22(1):14. doi: 10.1186/s12885-021-09095-7.
PubMed 34980020
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PIONEER-Panc: Phase II Investigations of New and Emerging Therapies for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04481204
- Acronym / sponsor ID
- 2020-0075
- Conditions
- Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 22 Jul 2020 (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 a phase II study using the Bayesian platform design. There are three clinical stage groups of localized pancreatic cancer: resectable, borderline resectable, and locally advanced disease. Each stage group will have a defined standard of care chemotherapy regimen for a control arm, serving as a basis of comparison. Each group may have one or more experimental arms. Experimental arms may be added to the platform over time, and the effects of the experimental treatments will be tested against the controls for each group.
Detailed description
PRIMARY OBJECTIVES:
- To estimate major pathological response rate. (Resectable and borderline resectable groups [treatment naive or previously treated]) II. To estimate 6-month disease control rate. (Locally advanced groups [treatment naive or previously treated])
SECONDARY OBJECTIVES:
- To measure progression free survival and overall survival. (Resectable and borderline resectable groups [treatment naive or previously treated]) II. To measure progression free survival and overall survival. (Locally advanced groups [treatment naive or previously treated])
EXPLORATORY OBJECTIVES:
- To benchmark tissue acquisition protocols for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) analysis in pancreatic ductal adenocarcinoma (PDAC).
II. To demonstrate concordance of cell free DNA detected mutations to those detected in the tumor-derived DNA in PDAC.
III. To demonstrate response through exosome and circulating tumor DNA. IV. To demonstrate response through the quantification of the immune activation by analyzing T and B cells, peripheral blood mononuclear cells, and tissue biopsies.
- To derive organoids from human PDAC and measure drug response in vitro. VI. To analyze the tumor microenvironment through immunohistochemistry (IHC) and hypoxia staining.
VII. To associate prognosis of patients with baseline and follow-up quantitative computed tomography (CT) image based analysis.
VIII. To associate clinical and pathological outcomes of patients with changes in radiomic measurements.
IX. To correlate quality of life for patients on standard and experimental therapies with laboratory, radiological, pathological, and clinical characteristics.
OUTLINE:Patients are assigned to different groups, and each group has a control arm. Within each group, the patient will be randomized to the appropriate control or an experimental arm. The control arms for the groups are:
Control arm for Group I (Treatment-naive resectable PDAC): Patients receive fluorouracil, irinotecan, leucovorin, and oxaliplatin (mFOLFIRINOX) for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity.
Control arm for Group II (Previously-treated resectable PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for up to 4 months in the absence of disease progression or unacceptable toxicity.
Control arm for Group III (Treatment-naive borderline resectable PDAC): Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
Control arm for Group IV (Previously-treated borderline resectable PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
Control arm for Group V (Treatment-naive locally advanced PDAC): Patients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
Control arm for Group VI (Previously-treated locally advanced PDAC): Patients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors.
After completion of study treatment, patients are followed up every 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control arm GroupI(mFOLFIRINOX) | Active comparator | Drug: Fluorouracil, Drug: Irinotecan, Drug: Leucovorin, Drug: OxaliplatinPatients receive mFOLFIRINOX for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity. |
| Control arm GroupII(chemotherapy, FOLFIRINOX) | Active comparator | Drug: Cisplatin, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Irinotecan, Drug: Leucovorin, Drug: Nab-paclitaxel, Drug: OxaliplatinPatients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for up to 4 months in the absence of disease progression or unacceptable toxicity. |
| Control arm GroupIII(FOLFIRINOX, radiation therapy) | Active comparator | Drug: Fluorouracil, Drug: Irinotecan, Drug: Leucovorin, Drug: Oxaliplatin, Radiation: Radiation TherapyPatients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors. |
| Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy) | Active comparator | Drug: Cisplatin, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Irinotecan, Drug: Leucovorin, Drug: Nab-paclitaxel, Drug: Oxaliplatin, Radiation: Radiation TherapyPatients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors. |
| Control arm GroupV(FOLFIRINOX, radiation therapy) | Active comparator | Drug: Fluorouracil, Drug: Irinotecan, Drug: Leucovorin, Drug: Oxaliplatin, Radiation: Radiation TherapyPatients receive FOLFIRINOX for 4-6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors |
| Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) | Active comparator | Drug: Cisplatin, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Irinotecan, Drug: Leucovorin, Drug: Nab-paclitaxel, Drug: Oxaliplatin, Radiation: Radiation TherapyPatients receive gemcitabine, gemcitabine and nab-paclitaxel, gemcitabine and cisplatin, or FOLFIRINOX for 6 months in the absence of disease progression or unacceptable toxicity. Patients may then undergo radiation therapy at the discretion of medical doctors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (83 listed)
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Pathologically proven adenocarcinoma of the pancreas by cytology or biopsy
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Confirmation of clinical stage of resectable
- TREATMENT NAIVE RESECTABLE PDAC COHORT: No prior chemotherapy or radiation therapy for PDAC
- TREATMENT NAIVE RESECTABLE PDAC COHORT: No current use of immunosuppressive medication
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Not pregnant and not nursing, for women of childbearing potential, a negative urine or blood pregnancy test done =< 7 days prior to registration is required
Key exclusion criteria (36 listed)
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Previous treatment for PDAC with chemotherapy or radiation
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Active malignancy, except basal cell carcinoma
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Staging other than resectable PDAC
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Known uncontrolled (grade >=2) or active gastric or duodenal ulcer disease within 30 days of enrollment
- TREATMENT NAIVE RESECTABLE PDAC COHORT: Prior surgical resection of pancreatic tumor
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 |
|---|---|---|
| CisplatinAlso: Abiplatin, Blastolem, Briplatin, CDDPGiven IV | Drug | Control arm GroupII(chemotherapy, FOLFIRINOX), Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy), Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) |
| FluorouracilAlso: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedioneGiven IV | Drug | Control arm GroupI(mFOLFIRINOX), Control arm GroupII(chemotherapy, FOLFIRINOX), Control arm GroupIII(FOLFIRINOX, radiation therapy), Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy), Control arm GroupV(FOLFIRINOX, radiation therapy), Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) |
| GemcitabineAlso: dFdC, dFdCyd, DifluorodeoxycytidineGiven IV | Drug | Control arm GroupII(chemotherapy, FOLFIRINOX), Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy), Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) |
| IrinotecanGiven IV | Drug | Control arm GroupI(mFOLFIRINOX), Control arm GroupII(chemotherapy, FOLFIRINOX), Control arm GroupIII(FOLFIRINOX, radiation therapy), Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy), Control arm GroupV(FOLFIRINOX, radiation therapy), Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) |
| LeucovorinAlso: Folinic acidGiven IV | Drug | Control arm GroupI(mFOLFIRINOX), Control arm GroupII(chemotherapy, FOLFIRINOX), Control arm GroupIII(FOLFIRINOX, radiation therapy), Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy), Control arm GroupV(FOLFIRINOX, radiation therapy), Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) |
| Nab-paclitaxelAlso: ABI 007, ABI-007, Abraxane, Albumin-bound PaclitaxelGiven IV | Drug | Control arm GroupII(chemotherapy, FOLFIRINOX), Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy), Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) |
| OxaliplatinAlso: 1-OHP, Ai Heng, Aiheng, DacotinGiven IV | Drug | Control arm GroupI(mFOLFIRINOX), Control arm GroupII(chemotherapy, FOLFIRINOX), Control arm GroupIII(FOLFIRINOX, radiation therapy), Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy), Control arm GroupV(FOLFIRINOX, radiation therapy), Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo RT | Radiation | Control arm GroupIII(FOLFIRINOX, radiation therapy), Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy), Control arm GroupV(FOLFIRINOX, radiation therapy), Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy) |
Primary outcome
Major pathological response rate
Time frame: 12 weeks
Major pathological response is any patient who has grade I or II treatment response. Grade I - 0% residual tumor cells in the specimen (pathologic complete response, grade II - 1 to < 5% residual tumor cells in the specimen.
Disease control rate
Time frame: 6 months
Measured as the proportion of patients without progression.
2 secondary outcomes
Progression free survival
Time frame: From the date of treatment initiation to the date of disease progression, recurrence after surgery or death from any cause whichever occurs first, assessed up to 5 years
Overall survival
Time frame: From treatment start till death or last follow-up if the patient is alive, assessed up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 34980020Douglas JE, Liu S, Ma J, Wolff RA, Pant S, Maitra A, Tamm EP, Bhosale P, Katz MHG, Varadhachary GR, Koay EJ. PIONEER-Panc: a platform trial for phase II randomized investigations of new and emerging therapies for localized pancreatic cancer. BMC Cancer. 2022 Jan 3;22(1):14. doi: 10.1186/s12885-021-09095-7.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Eugene J Koay principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Fluorouracil and Gemcitabine in people with Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma, run by M.D. Anderson Cancer Center.
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 83 inclusion and 36 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: withdrawn, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481204, which also lists 1 linked publication.
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 4 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.