Acoustic Cluster Therapy + Chemotherapy for Pancreatic Cancer
(ENACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for individuals with locally advanced pancreatic cancer. It evaluates the effectiveness and safety of Acoustic Cluster Therapy (ACT) when added to a standard chemotherapy regimen called modified FOLFIRINOX. The trial targets those who cannot undergo surgery to remove their cancer but are eligible for modified FOLFIRINOX. Individuals who have received previous treatments for pancreatic cancer are not eligible, though those with a bile duct stent or who have undergone a palliative procedure can still participate. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Acoustic Cluster Therapy (ACT), combined with a modified FOLFIRINOX chemotherapy, is under careful study for safety in treating pancreatic cancer. Earlier studies found that patients generally tolerate this combination well. Some side effects have been reported, but they are similar to those expected with chemotherapy treatments.
The trial is now in Phase 2, indicating that earlier research suggested the treatment is safe enough for testing in more people. This phase focuses on understanding how the body reacts to the treatment and any potential side effects. While specific results from this trial aren't available yet, being in Phase 2 suggests that earlier stages likely addressed any major safety concerns.
Prospective participants should consult their doctor to understand what the treatment involves and what side effects to expect.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Acoustic Cluster Therapy (ACT) with modified FOLFIRINOX for pancreatic cancer because it introduces an innovative way to enhance chemotherapy effectiveness. Unlike traditional chemotherapy which relies solely on the direct action of drugs, ACT uses sound waves to temporarily increase the permeability of tumor blood vessels, allowing for better drug delivery directly to the cancer cells. This novel approach could potentially increase the effectiveness of the treatment while minimizing damage to healthy tissue, which is a significant advancement over current options like standard FOLFIRINOX chemotherapy.
What evidence suggests that Acoustic Cluster Therapy with chemotherapy could be effective for pancreatic cancer?
Research shows that Acoustic Cluster Therapy (ACT) can enhance the effectiveness of chemotherapy. In earlier studies, patients with tumors who received both ACT and chemotherapy experienced significantly greater tumor shrinkage compared to those who received only chemotherapy. For instance, in colorectal cancer cases, the combination of ACT and chemotherapy resulted in a 29% reduction in tumor size, while chemotherapy alone achieved just a 7% reduction. Additionally, using ACT with chemotherapy increased the likelihood of completely eliminating the tumor by 7.2 times. This trial will evaluate the effectiveness of ACT combined with modified FOLFIRINOX chemotherapy for patients with locally advanced pancreatic cancer, as these results suggest that ACT might improve treatment outcomes.16789
Are You a Good Fit for This Trial?
This trial is for individuals with inoperable or borderline resectable locally advanced pancreatic cancer who are not candidates for primary curative surgery. Participants must be suitable to receive mFOLFIRINOX chemotherapy as determined by the study's investigator.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Acoustic Cluster Therapy (ACT) with modified FOLFIRINOX chemotherapy in up to eight 2-week cycles
Efficacy Assessment
Objective efficacy of the treatment is assessed by CT scans
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acoustic Cluster Therapy
- Modified FOLFIRINOX
Find a Clinic Near You
Who Is Running the Clinical Trial?
EXACT Therapeutics AS
Lead Sponsor