Imaging-Guided Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Harrison Kim, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Prior chemotherapy, Prior radiation, Pregnancy, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this study is to test whether chemotherapy guided by a new imaging method named DCE-MRI can more effectively reduce a pancreatic tumor, enabling curable surgery, over the conventional method when a tumor is categorized as borderline resectable pancreatic cancer. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast-enhanced magnetic resonance imaging, or DCE-MRI, for over 10 years. This technique has been globally used to calculate the blood flow of various tissues, including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor typically has low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy can result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and deciding whether to continue the therapy or try a different one.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Imaging-Guided Chemotherapy for Pancreatic Cancer?

Research shows that neoadjuvant chemotherapy (treatment given before surgery) can improve survival rates and increase the chances of successful surgery in pancreatic cancer patients. Studies indicate that this approach can lead to better outcomes by shrinking tumors and making them easier to remove. ^{1 2 3 4 5}

Is imaging-guided chemotherapy for pancreatic cancer safe for humans?

Neoadjuvant chemotherapy, which is similar to imaging-guided chemotherapy, has been shown to be generally safe for humans, with studies indicating it can be administered before surgery to most patients with pancreatic cancer. However, like many chemotherapy treatments, it can have frequent adverse events (side effects). ^{1 4 5 6 7}

How is neoadjuvant chemotherapy different from other treatments for pancreatic cancer?

Neoadjuvant chemotherapy is given before surgery to shrink tumors in pancreatic cancer, making them easier to remove and increasing the chances of successful surgery. This approach is different from traditional treatments that typically involve surgery first, followed by chemotherapy. ^{2 5 8 9 10}

Research Team

Harrison Kim, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for individuals with borderline resectable pancreatic cancer. It's designed to see if a new imaging method can help make tumors small enough for surgery. Participants should be eligible for chemotherapy and have no conditions that would interfere with MRI imaging.

Inclusion Criteria

I have been diagnosed with pancreatic cancer that might be removable by surgery.

I am 19 years old or older.

Patients with signed informed consent

Exclusion Criteria

Participants who are pregnant, lactating or are planning to become pregnant during the study

Participants with safety contraindications to MRI examination (determined by standard clinical screening)

I have had treatment or surgery for pancreatic cancer before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DCE-MRI guided neoadjuvant chemotherapy to reduce pancreatic tumor size

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Neoadjuvant Chemotherapy (Chemotherapy)

Trial Overview The study tests whether DCE-MRI guided chemotherapy is more effective than standard treatment in shrinking pancreatic tumors to allow surgery. The technique measures blood flow changes in the tumor to assess therapy effectiveness early on.

Participant Groups

Group I: borderline-resectable pancreatic cancer (BRPC) Experimental Treatment 1 Intervention

Neoadjuvant Chemotherapy is already approved in Canada, Japan, China for the following indications:

Approved in Canada as Neoadjuvant Chemotherapy for:

• Breast cancer
• Ovarian cancer
• Colorectal cancer
• Lung cancer
• Esophageal cancer

Approved in Japan as Neoadjuvant Chemotherapy for:

• Breast cancer
• Ovarian cancer
• Colorectal cancer
• Lung cancer
• Esophageal cancer
• Stomach cancer

Approved in China as Neoadjuvant Chemotherapy for:

• Breast cancer
• Ovarian cancer
• Colorectal cancer
• Lung cancer
• Esophageal cancer
• Stomach cancer

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

In a randomized phase II trial involving 51 patients with borderline-resectable pancreatic cancer, neoadjuvant chemotherapy using either FOLFIRINOX or GEM/nab-PTX was found to be feasible and well tolerated, achieving an R0 resection rate of 67.4%.

The study reported a 3-year overall survival rate of 54.7% and a median survival time of 39.4 months, indicating that neoadjuvant chemotherapy can provide significant survival benefits despite a notable incidence of adverse events (45.1% experienced grade >3 adverse events).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a Phase II Study on the Use of Neoadjuvant Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-resectable Pancreatic Cancer (NUPAT-01). Yamaguchi, J., Yokoyama, Y., Fujii, T., et al.[2023]

In a study of 680 patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma, 92.9% received chemotherapy, with a completion rate of 71.6%, highlighting good treatment compliance.

The study found that patients who completed chemotherapy and underwent surgery had significantly better survival rates, with a median survival of 35.4 months for those initially borderline resectable and 41.8 months for those initially locally advanced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Primary Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma. Maggino, L., Malleo, G., Marchegiani, G., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neoadjuvant Treatment for Pancreatic Cancer. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Radiological evaluation of response to neoadjuvant treatment in pancreatic cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Overall survival is increased among stage III pancreatic adenocarcinoma patients receiving neoadjuvant chemotherapy compared to surgery first and adjuvant chemotherapy: An intention to treat analysis of the National Cancer Database. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Perioperative and Survival Outcomes Following Neoadjuvant FOLFIRINOX versus Gemcitabine Abraxane in Patients with Pancreatic Adenocarcinoma. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Results of a Phase II Study on the Use of Neoadjuvant Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-resectable Pancreatic Cancer (NUPAT-01). [2023]

7. England pubmed.ncbi.nlm.nih.gov

Randomized phase II study of chemoradiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer: Japan Clinical Oncology Group trial, JCOG1106. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

Present status and perspective of perioperative chemotherapy for patients with resectable pancreatic cancer in Japan. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Primary Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Contemporary trials evaluating neoadjuvant therapy for resectable pancreatic cancer. [2021]