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Antimetabolites

Chemotherapy +/− Radiation before Surgery for Pancreatic Cancer

Phase 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days of registration

No prior chemotherapy or radiation for pancreatic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a combination of chemotherapy drugs with or without radiation therapy before surgery to see if it is more effective in treating pancreatic cancer.

Who is the study for?

This trial is for patients with pancreatic cancer that can potentially be removed by surgery. They must not have had previous chemotherapy or radiation, no severe neuropathy, uncontrolled ulcers, or certain genetic conditions like Gilbert's syndrome. Participants need to have a good performance status and adequate organ function as indicated by blood tests.Check my eligibility

What is being tested?

The study is testing how well combination chemotherapy (mFOLFIRINOX) works when given with or without hypofractionated radiation therapy before surgery. The goal is to see if the addition of this type of radiation therapy improves outcomes in treating pancreatic cancer.See study design

What are the potential side effects?

Possible side effects include reactions from the chemotherapy drugs such as nausea, fatigue, nerve damage (neuropathy), and low blood counts leading to increased infection risk. Radiation may cause skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had severe stomach ulcers in the last month.

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I have not had chemotherapy or radiation for pancreatic cancer.

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I do not have Gilbert's syndrome or a specific genetic condition.

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My scans show my cancer is almost operable, confirmed by a central review.

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My kidney function, measured by creatinine levels, is within the normal range.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My pancreatic cancer has not been surgically removed.

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I do not have severe numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS) Rate

Secondary outcome measures

Event-free Survival

Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE

Pathologic Complete Rate (pCR) Rate

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: mFOLFIRINOX + surgery + FOLFOXExperimental Treatment3 Interventions

Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.

Group II: mFOLFIRINOX + radiation + surgery + FOLFOXExperimental Treatment4 Interventions

Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

surgery

2005

Completed Phase 4

~6010

radiation therapy

1994

Completed Phase 3

~13390

mFOLFIRINOX

2013

Completed Phase 2

~40

FOLFOX

2009

Completed Phase 3

~4560

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sky FoundationUNKNOWN

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,512 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,027 Total Patients Enrolled

Media Library

Fluorouracil (Antimetabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02839343 — Phase 2

Pancreatic Adenocarcinoma Research Study Groups: mFOLFIRINOX + radiation + surgery + FOLFOX, mFOLFIRINOX + surgery + FOLFOX

Pancreatic Adenocarcinoma Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT02839343 — Phase 2

Fluorouracil (Antimetabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02839343 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial currently open for enrollment?

"As indicated by the clinicaltrials.gov listing, this medical trial is not currently recruiting patients. Initially posted on December 1st 2016 and last updated on April 28th 2022, it does not appear that any new participants are being sought out for now. Nonetheless, there are 787 other trials actively enrolling people at present time."

Answered by AI

What beneficial outcomes are being sought with this medical experiment?

"The primary endpoint of this 18 month clinical trial is the overall survival rate (OS). Additionally, researchers plan to examine pathologic complete response rates among both cohorts using chi-square tests or Fisher's exact test. Secondary endpoints include event-free survival, which will be estimated with Kaplan-Meier methods and compared between treatment groups by log rank testing, as well as residual tumor R0 resection rate that will also be analyzed for correlation with OS/progression free survival via Cox models and landmark approach."

Answered by AI

What potential risks are associated with radiation treatment?

"Taking into account the fact that radiation therapy is in a Phase 2 trial, our team at Power assigned it a safety score of 2 as there has been some progress made towards proving its security but no evidence to back up its effectiveness."

Answered by AI

How many sites are hosting this clinical investigation?

"Currently, 100 different trial sites are actively hosting this clinical investigation. These locations include Houston, Portland, Seattle and more; it would be beneficial to select the nearest site in order to reduce travel commitments if you decide to participate."

Answered by AI

Recent research and studies

BMC CancerJournal

Alliance for Clinical Trials in Oncology (ALLIANCE) Trial A021501: Preoperative Extended Chemotherapy Vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

Katz, Matthew H. G., for the Alliance for Clinical Trials on Oncology, Fang-Shu Ou, Joseph M. Herman, Syed A. Ahmad, Brian Wolpin, Robert Marsh, et al.. 2017. “Alliance for Clinical Trials in Oncology (ALLIANCE) Trial A021501: Preoperative Extended Chemotherapy Vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-017-3441-z.

BMC CancerJournal

JAMA OncologyJournal

Efficacy of Preoperative Mfolfirinox Vs Mfolfirinox Plus Hypofractionated Radiotherapy for Borderline Resectable Adenocarcinoma of the Pancreas

Katz, Matthew H. G., Qian Shi, Jeff Meyers, Joseph M. Herman, Michael Chuong, Brian M. Wolpin, Syed Ahmad, et al.. 2022. “Efficacy of Preoperative Mfolfirinox Vs Mfolfirinox Plus Hypofractionated Radiotherapy for Borderline Resectable Adenocarcinoma of the Pancreas”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2022.2319.

clinicaltrials.govStudy

Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer

2016. "Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02839343.