Chemotherapy 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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

ORR by RECIST 1.1 and duration of response in patients receiving mFFX or GA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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