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Anti-tumor antibiotic

Modified Folfirinox for Pancreatic Cancer (PASS-01 Trial)

Phase 2

Waitlist Available

Research Sponsored by University Health Network, Toronto

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 2-4 years

Awards & highlights

PASS-01 Trial Summary

This trial will compare two chemotherapy regimens for pancreatic cancer. It will also study how well the cancer responds to different treatments, and look for biomarkers that could predict treatment response.

Who is the study for?

Adults with untreated metastatic pancreatic ductal adenocarcinoma can join this trial if they're fit for chemotherapy, have a life expectancy over 90 days, and can undergo a tumor biopsy. They must not have other serious health issues or prior PDAC treatments. Women of childbearing age need a negative pregnancy test and must use birth control.Check my eligibility

What is being tested?

The study compares two standard chemo treatments for advanced pancreatic cancer: modified Folfirinox (mFFX) and Gemcitabine/nab-paclitaxel (GA). It includes molecular profiling to tailor treatment to the patient's specific cancer signature.See study design

What are the potential side effects?

Common side effects of mFFX and GA include fatigue, nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, hair loss, numbness in fingers/toes, and allergic reactions.

PASS-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-4 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression free survival(PFS) in mFFX and GA arms pancreatic ductal adenocarcinoma (PDAC) in a randomized phase II trial.

Secondary outcome measures

Cell free circulating tumor (ct) DNA analysis (including KRAS mutational status)

Cluster Tendency analysis using artificial neural networks and radiomic methods combined

GATA6 as a biomarker of response to mFFX or GA

+5 more

PASS-01 Trial Design

2Treatment groups

Active Control

Group I: Modified FolfirinoxActive Control1 Intervention

Modified FOLFIRINOX (Folinic acid/Leucovorin, 5-Fluouracil, Irinotecan, Oxaliplatin) administered intravenously. Given that both regimens are standard of care, study treatment will be administered as per standard of care at each institution including a maintenance therapy approach which is encouraged in both arms. Dose modifications, anti-emetics, supportive medications, and use of growth factors should follow institutional guidelines.

Group II: Gemcitabine/nab-PaclitaxelActive Control1 Intervention

Gemcitabine/nab-Paclitaxel administered intravenously. Given that both regimens are standard of care, study treatment will be administered as per standard of care at each institution including a maintenance therapy approach which is encouraged in both arms. Dose modifications, anti-emetics, supportive medications, and use of growth factors should follow institutional guidelines.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stand Up To CancerOTHER

51 Previous Clinical Trials

40,186 Total Patients Enrolled

Cold Spring Harbor LaboratoryOTHER

10 Previous Clinical Trials

19,992 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterOTHER

1,937 Previous Clinical Trials

588,170 Total Patients Enrolled

Frequently Asked Questions

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

What are the chief medical benefits of Modified Folfirinox?

"Carcinomas such as non-small cell lung carcinoma, rectal carcinoma, and other malignant neoplasms can be managed through Modified Folfirinox."

Answered by AI

How many willing individuals are part of this experiment?

"Yes, the clinicaltrials.gov website contains information showing that this trial is still looking for participants. The listing was first posted on October 14th 2020 and updated most recently on April 12th 2022. So far, 150 patients have been recruited from 6 different locations."

Answered by AI

Are there any dangers patients should know about before taking Modified Folfirinox?

"While there is some data suggesting that the Modified Folfirinox intervention is safe, none of it points to the efficacy of the treatment. Therefore, our team has given it a score of 2."

Answered by AI

Can you tell me what other research studies have been done that are similar to this one using Modified Folfirinox?

"Currently, 1700 clinical trials are underway to study the effects of modified Folfirinox. 495 of those trials are in Phase 3. Most of the studies for Modified Folfirinox are based in Guangzhou, Guangdong; however, there are 83029 locations running similar studies."

Answered by AI

Are participants still being recruited for this research project?

"That is correct. The clinicaltrials.gov website has information indicating that this trial, which was first advertised on October 14th 2020, is still looking for participants. They need a total of 150 patients from 6 different locations."

Answered by AI

Is this trial active in several places throughout North America?

"There are six sites currently running this trial, three of which are located in Baltimore, Boston and Vancouver. The other locations may be closer to you, lessening the inconvenience of travel should you choose to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pancreatic Adenocarcinoma Signature Stratification for Treatment

2020. "Pancreatic Adenocarcinoma Signature Stratification for Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04469556.