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Alkylating agents
Chemotherapy + Radiation Therapy for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Eugene J Koay
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treatment Naive Resectable PDAC Cohort: Absolute neutrophil count (ANC) >= 1,500/mm^3
Treatment Naive Resectable PDAC Cohort: Calculated (Calc.) creatinine clearance > 45 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start till death or last follow-up if the patient is alive, assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing new treatments for pancreatic cancer against standard chemotherapy.
Who is the study for?
Adults with resectable, borderline resectable, or locally advanced pancreatic cancer. Must not be pregnant/nursing and have a life expectancy over 6 months. Eligible participants need normal organ function (blood counts, liver/kidney tests within certain limits) and no prior treatments for those treatment-naive or only specific past chemotherapies for the previously treated.Check my eligibility
What is being tested?
The PIONEER-Panc study is testing various chemotherapy drugs (Cisplatin, Irinotecan, Oxaliplatin, Leucovorin, Fluorouracil) and Nab-paclitaxel plus Gemcitabine against standard care in different stages of pancreatic cancer using a phase II Bayesian platform design to determine their effectiveness.See study design
What are the potential side effects?
Potential side effects include nausea/vomiting from chemotherapy; numbness/tingling due to nerve damage; low blood cell counts leading to increased infection risk or bleeding; fatigue; hair loss; kidney/liver function changes. Radiation may cause skin irritation and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is high enough for treatment.
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My kidneys work well enough (creatinine clearance over 45 mL/min).
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My creatinine levels are within normal range.
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My kidneys work well enough (creatinine clearance over 45 mL/min).
Select...
My kidneys work well enough (creatinine clearance over 45 mL/min).
Select...
My platelet count is at least 100,000/mm^3.
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My pancreatic cancer is at a stage where surgery might be possible.
Select...
My doctor expects me to live more than 6 months.
Select...
My total bilirubin level is 2.0 mg/dL or less.
Select...
My white blood cell count is high enough for treatment.
Select...
My pancreas cancer was confirmed by a lab test.
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My pancreatic cancer is confirmed by tests and hasn't been treated yet.
Select...
My pancreatic cancer is at a stage where surgery might be possible.
Select...
My total bilirubin level is 2.0 mg/dL or less.
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I am not currently taking any medication that weakens my immune system.
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My doctor expects me to live more than 6 months.
Select...
I am very active or have minor symptoms from my cancer.
Select...
My doctor expects me to live more than 6 months.
Select...
My kidneys work well enough for treatment (creatinine clearance > 45 mL/min).
Select...
My platelet count is at least 100,000/mm^3.
Select...
I am not currently taking any immunosuppressive medications.
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My kidney function, measured by creatinine, is within normal limits.
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I am not currently taking any immunosuppressive medications.
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My hemoglobin level is at least 8.0 mg/dL.
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I have not received any treatment for pancreatic cancer.
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My kidneys work well enough (creatinine clearance over 45 mL/min).
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I am very active or have minor limitations in physical activity.
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My pancreatic cancer is confirmed as locally advanced.
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I am very active or have minor restrictions in physical activity.
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My liver enzymes are within the normal range.
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My white blood cell count is healthy for cancer treatment.
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My pancreatic cancer diagnosis was confirmed through a biopsy or cytology.
Select...
My kidneys work well enough (creatinine clearance over 45 mL/min).
Select...
My white blood cell count is high enough for treatment.
Select...
My creatinine levels are within normal range.
Select...
My pancreatic cancer was confirmed by a lab test.
Select...
I have not received any treatment for my advanced pancreatic cancer.
Select...
My kidney function is normal, based on my creatinine levels.
Select...
My platelet count is at least 100,000/mm^3.
Select...
My platelet count is at least 100,000/mm^3.
Select...
I have not had chemotherapy or radiation for pancreatic cancer.
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My pancreatic cancer is confirmed to be at a stage where surgery is possible.
Select...
My doctor expects me to live more than 6 months.
Select...
I have a confirmed diagnosis of pancreatic cancer.
Select...
I am not currently taking any medication that weakens my immune system.
Select...
I am very active or have minor symptoms from my cancer.
Select...
My pancreatic cancer diagnosis was confirmed through a biopsy or cytology.
Select...
My pancreatic cancer is in a stage where surgery is possible.
Select...
My total bilirubin level is 2.0 mg/dL or less.
Select...
I have not received any chemotherapy or radiation for pancreatic cancer.
Select...
My doctor expects me to live more than 6 months.
Select...
I have pancreatic cancer and can care for myself but may not be able to do heavy physical work.
Select...
I am not taking any immunosuppressive drugs.
Select...
I am not currently taking any medication that weakens my immune system.
Select...
My total bilirubin level is 2.0 mg/dL or lower.
Select...
My pancreatic cancer was confirmed by a lab test.
Select...
My white blood cell count is high enough for treatment.
Select...
My doctor expects me to live more than 6 months.
Select...
My pancreatic cancer is at a stage where surgery is possible.
Select...
My doctor expects me to live more than 6 months.
Select...
My total bilirubin level is 2.0 mg/dL or less.
Select...
My liver enzymes are within the normal range.
Select...
My white blood cell count is high enough for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from treatment start till death or last follow-up if the patient is alive, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start till death or last follow-up if the patient is alive, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate
Major pathological response rate
Secondary outcome measures
Overall survival
Progression free survival
Trial Design
6Treatment groups
Active Control
Group I: Control arm GroupI(mFOLFIRINOX)Active Control4 Interventions
Patients receive mFOLFIRINOX for 3 months before and after surgery in the absence of disease progression or unacceptable toxicity.
Group II: Control arm GroupII(chemotherapy, FOLFIRINOX)Active Control7 Interventions
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.
Group III: Control arm GroupIII(FOLFIRINOX, radiation therapy)Active Control5 Interventions
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.
Group IV: Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)Active Control8 Interventions
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
Group V: Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy)Active Control8 Interventions
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.
Group VI: Control arm GroupV(FOLFIRINOX, radiation therapy)Active Control5 Interventions
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,266 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,403 Total Patients Enrolled
Eugene J KoayPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
225 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My white blood cell count is high enough for treatment.My kidneys work well enough (creatinine clearance over 45 mL/min).I have had standard chemotherapy for pancreatic cancer before.I do not have serious heart rhythm problems.My creatinine levels are within normal range.My kidneys work well enough (creatinine clearance over 45 mL/min).I have a cancer other than basal cell carcinoma that hasn't been treated yet.My kidneys work well enough (creatinine clearance over 45 mL/min).I have a good level of physical activity despite having advanced pancreatic cancer.My pancreatic cancer was not just in the pancreas when diagnosed.My pancreatic cancer is not yet treated and is considered borderline resectable.I am not pregnant or breastfeeding.My pancreatic cancer is at a stage where surgery might be possible.My doctor expects me to live more than 6 months.My total bilirubin level is 2.0 mg/dL or less.My white blood cell count is high enough for treatment.My pancreas cancer was confirmed by a lab test.I am not pregnant or nursing and have a recent negative pregnancy test.My pancreatic cancer is confirmed by tests and hasn't been treated yet.I have an active cancer other than basal cell carcinoma.I have had severe stomach or duodenal ulcers in the last month.My pancreatic cancer is at a stage where surgery might be possible.My total bilirubin level is 2.0 mg/dL or less.I am not currently taking any medication that weakens my immune system.My pancreatic cancer is confirmed to be at an advanced local stage.I am very active or have minor symptoms from my cancer.I have not had severe or active stomach ulcers in the last 30 days.I have severe heart failure and was diagnosed less than 6 months ago.I have severe active ulcers in my stomach or upper intestine.I or my partner can't or won't use effective birth control during the study.I am not pregnant or nursing and have a recent negative pregnancy test.I am not pregnant or nursing and have a recent negative pregnancy test.My doctor expects me to live more than 6 months.My kidneys work well enough for treatment (creatinine clearance > 45 mL/min).My platelet count is at least 100,000/mm^3.My kidney function, measured by creatinine, is within normal limits.I am not currently taking any immunosuppressive medications.My hemoglobin level is at least 8.0 mg/dL.I am currently taking cancer treatment not listed in this study's protocol.I have not received any treatment for pancreatic cancer.I am very active or have minor limitations in physical activity.My pancreatic cancer is confirmed as locally advanced.I have not had surgery for my pancreatic tumor yet.I am very active or have minor restrictions in physical activity.My liver enzymes are within the normal range.I have an active cancer other than basal cell carcinoma.I am not pregnant or nursing and have a recent negative pregnancy test.I have an active, uncontrolled HIV, hepatitis B, or hepatitis C infection.My white blood cell count is healthy for cancer treatment.I am allergic to iodine or gadolinium used in some medical scans.My pancreatic cancer diagnosis was confirmed through a biopsy or cytology.I have an active, uncontrolled HIV, hepatitis B, or hepatitis C infection.My kidneys work well enough (creatinine clearance over 45 mL/min).My doctor expects me to live more than 6 months.I am not currently taking any immunosuppressive medications.My platelet count is at least 100,000/mm^3.I do not have serious heart rhythm problems.My pancreatic cancer is in a stage where surgery is possible.I have not received chemotherapy or radiation for my borderline resectable pancreatic cancer.My kidneys work well enough (creatinine clearance over 45 mL/min).I have not received any treatment for my pancreatic cancer.My white blood cell count is high enough for treatment.My creatinine levels are within normal range.I am allergic to iodine-based or gadolinium-based IV contrasts.My pancreatic cancer was confirmed by a lab test.I have severe heart failure diagnosed within the last 6 months.I have had standard chemotherapy for pancreatic cancer before.I have not received any treatment for my advanced pancreatic cancer.My kidney function is normal, based on my creatinine levels.I have had surgery to remove a pancreatic tumor and have not received any other treatment.My platelet count is at least 100,000/mm^3.My platelet count is at least 100,000/mm^3.I have not had chemotherapy or radiation for pancreatic cancer.I have had radiation therapy to my abdomen before.My pancreatic cancer is confirmed to be at a stage where surgery is possible.My doctor expects me to live more than 6 months.I have a confirmed diagnosis of pancreatic cancer.I am not currently taking any medication that weakens my immune system.I have had standard chemotherapy for pancreatic cancer before.I am very active or have minor symptoms from my cancer.I cannot have iodine or gadolinium contrast due to allergies or other reasons.I am not pregnant or nursing and have a recent negative pregnancy test.I have severe heart failure and was diagnosed less than 6 months ago.My pancreatic cancer diagnosis was confirmed through a biopsy or cytology.My pancreatic cancer is in a stage where surgery is possible.My total bilirubin level is 2.0 mg/dL or less.I have not received any chemotherapy or radiation for pancreatic cancer.My doctor expects me to live more than 6 months.I have pancreatic cancer and can care for myself but may not be able to do heavy physical work.I am not taking any immunosuppressive drugs.I am not currently taking any medication that weakens my immune system.My total bilirubin level is 2.0 mg/dL or lower.My pancreatic cancer was confirmed by a lab test.I have not received chemotherapy or radiation for my pancreatic cancer.I had surgery to remove a pancreatic tumor.I do not have serious heart rhythm problems.I am not pregnant or nursing and have a recent negative pregnancy test.I am very active or have minor restrictions in physical activity.My white blood cell count is high enough for treatment.I or my partner are not using effective birth control methods.My doctor expects me to live more than 6 months.My pancreatic cancer is at a stage where surgery is possible.My doctor expects me to live more than 6 months.My total bilirubin level is 2.0 mg/dL or less.My liver enzymes are within the normal range.For patients with a type of pancreatic cancer that can be surgically removed and have not yet received treatment, their creatinine level must be within a certain normal range.I am pregnant or breastfeeding and have a treatable form of pancreatic cancer.My white blood cell count is high enough for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Control arm GroupI(mFOLFIRINOX)
- Group 2: Control arm GroupII(chemotherapy, FOLFIRINOX)
- Group 3: Control arm GroupIII(FOLFIRINOX, radiation therapy)
- Group 4: Control arm GroupVI(chemotherapy,FOLFIRINOX,radiation therapy)
- Group 5: Control arm GroupIV(chemotherapy,FOLFIRINOX,radiation therapy)
- Group 6: Control arm GroupV(FOLFIRINOX, radiation therapy)
Awards:
This trial has 1 awards, including:- 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.
Are there any available openings to participate in this trial?
"This trial is no longer enrolling new patients; its posting date was November 30th 2022 and it was last updated on June 29th 2022. For those seeking alternative studies, there are 769 clinical trials actively recruiting individuals with resectable pancreatic ductal adenocarcinoma (PDAC) as well as 2022 trials specifically concerning the Control arm GroupI(mFOLFIRINOX)."
Answered by AI
What is the maximum number of participants enrolled in this study?
"This medical study has concluded its recruitment phase. It was initially launched on November 30th 2022 and last modified on June 29th of the same year. Nevertheless, there are 769 studies recruiting patients with resectable pancreatic ductal adenocarcinoma (pdac) as well as 2022 clinical trials for Control arm GroupI(mFOLFIRINOX)."
Answered by AI
Has the efficacy of mFOLFIRINOX been explored in other research initiatives?
"Currently, 2022 clinical trials concerning Control arm GroupI(mFOLFIRINOX) are in progress with 611 of them being Phase 3. With the majority of these tests occurring in Guangzhou, Guangdong, there is a total of 101509 locations that have conducted such studies."
Answered by AI
To what ailments is Control arm GroupI(mFOLFIRINOX) typically employed?
"Group I (mFOLFIRINOX) is a control arm employed to treat malignant esophageal neoplasms while also being effective in addressing actinic keratosis, preventing central volume depletion, and counteracting the effects of prior anthracycline-based therapies."
Answered by AI
Has the FDA approved mFOLFIRINOX as part of Control arm GroupI?
"Since Control arm GroupI (mFOLFIRINOX) is only in Phase 2, there is some evidence of safety but none regarding efficacy. We here at Power have assigned a score of 2 to this treatment's safety rating."
Answered by AI
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