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NALIRIFOX + Radiation for Pancreatic Cancer
Phase 2
Recruiting
Led By Alice Wei, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial investigates if a combination of drugs and radiation therapy can effectively treat pancreatic cancer in combination with surgery, and with few side effects, and measure quality of life.
Who is the study for?
This trial is for adults over 18 with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) that hasn't been treated before. They must be in good health, have no history of certain cancers within the last 5 years except some specific types, and women must not be pregnant and agree to birth control measures. Men must also agree to use contraception.Check my eligibility
What is being tested?
The study tests a chemotherapy regimen called NALIRIFOX combined with ablative dose radiation therapy (AD-XRT) and capecitabine before surgery in patients with PDAC. It aims to assess if this total neoadjuvant therapy (TNT) sequence is effective and tolerable, while also monitoring participants' quality of life through questionnaires.See study design
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues such as fatigue, digestive problems like nausea or diarrhea, blood cell count changes leading to increased infection risk, possible liver function alterations, and reactions related to the infusion process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
event-free survival (EFS)
Secondary outcome measures
overall survival (OS) rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: NALIRIFOX + AD-XRT and capecitabineExperimental Treatment2 Interventions
Patients will receive neoadjuvant chemotherapy for 4 months. Patients will undergo a CT scan at 8 weeks and 16 weeks after the start of neoadjuvant chemotherapy to assess treatment response. Patients without disease progression will then undergo AD-XRT for 15 to 25 fractions (3 to 5 weeks). Patient's whose disease is deemed resectable based on their re-evaluating imaging, will be recommended surgical intervention with consideration for laparotomy or laparoscopy if deemed appropriate at multidiscplinary cancer conference review.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,838 Total Patients Enrolled
IpsenIndustry Sponsor
346 Previous Clinical Trials
73,240 Total Patients Enrolled
Pancreatic Cancer Research FundUNKNOWN
1 Previous Clinical Trials
3,500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult over 18 and not pregnant or breastfeeding.I was diagnosed and treated for certain early-stage cancers or skin cancer within the last 5 years.I am willing and able to follow the study's procedures and attend all visits.I do not have any infections that could make treatment dangerous, except for possibly resolving cholangitis.I agree to use two forms of birth control during and for 9 months after the study.My white blood cell count is healthy without needing medication to boost it.I am fully active or can carry out light work.My cancer cannot be removed by surgery, but I have recovered from the surgical exploration.My kidney function is good, with creatinine levels below 1.6 mg/dL.My treatment plan was agreed upon by a team of cancer specialists.I have health conditions that make major abdominal surgery too risky.I have had chemotherapy, radiotherapy, or surgery for pancreatic cancer.I've been cancer-free from another type for 2+ years and at low risk of it coming back.I am not pregnant or have been without a period for at least 2 years.I do not have severe nerve pain or damage.My cancer is not adenocarcinoma, but adenosquamous types are okay.I agree to use condoms for 4 months after the last dose of the study medication.My pancreatic cancer is confirmed but not yet treated.My pancreatic cancer has spread to other parts of my body.My blood clotting time is normal or managed if I'm on blood thinners.My pancreatic cancer is locally advanced without spread to distant parts.
Research Study Groups:
This trial has the following groups:- Group 1: NALIRIFOX + AD-XRT and capecitabine
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.
At which sites can individuals access this clinical trial?
"There are currently 7 sites registering patients for this trial, with locations in Middletown, Montvale and Commack as well as other cities. For minimal travel requirements it is best to select the closest medical centre when enrolling."
Answered by AI
What degree of safety should a patient expect while undergoing treatment with NALIRIFOX + AD-XRT and capecitabine?
"Our assessment of NALIRIFOX + AD-XRT and capecitabine's safety has been rated as a 2, indicating that there is preliminary evidence for the drug's security but not its efficacy."
Answered by AI
Are there still opportunities for participants to join this trial?
"Based on the clinicaltrials.gov database, this trial is not currently accepting patients. The original post date was May 1st 2023 and has since been updated; however, 811 other trials are still in search of volunteers to participate right now."
Answered by AI
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