Imaging-Guided Chemotherapy for Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Sebastian Eady, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Prior chemotherapy, Prior radiation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

50 Participants Needed

Trial Summary

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}

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.

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.

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

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 European Union, United States, Canada, Japan, China for the following indications:

Approved in European Union as Neoadjuvant Chemotherapy for:

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

Approved in United States as Neoadjuvant Chemotherapy for:

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

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+

Findings from Research

Neoadjuvant chemotherapy, either alone or with radiation, is being used to improve surgical options for patients with pancreatic ductal adenocarcinoma (PDAC), which is often diagnosed at an advanced stage, making surgery difficult.

Current evidence suggests that neoadjuvant therapy can increase the rates of successful tumor resections (R0 resection rates) and improve overall survival, with combination regimens like modified FOLFIRNOX and gemcitabine/nab-paclitaxel showing resection rates of up to 68% for borderline resectable PDAC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant Treatment for Pancreatic Cancer. Raufi, AG., Manji, GA., Chabot, JA., et al.[2022]

Neoadjuvant chemotherapy is increasingly used for patients with non-metastatic pancreatic adenocarcinoma to better identify candidates for surgical resection and to increase the number of patients eligible for surgery.

Evaluating the tumor's response to neoadjuvant therapy through imaging is challenging for pancreatic cancer, highlighting the need for improved assessment methods post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiological evaluation of response to neoadjuvant treatment in pancreatic cancer. Cassinotto, C., Sa-Cunha, A., Trillaud, H.[2022]

In a study of 593 patients with clinical stage III pancreatic adenocarcinoma, those who received neoadjuvant chemotherapy had a significantly better overall survival rate (20.7 months) compared to those who underwent surgery first (13.7 months).

The analysis indicated that neoadjuvant therapy reduced the risk of mortality by 32% compared to surgery-first, highlighting its potential effectiveness in improving outcomes for these patients.

NCBI (Pubmed)

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. Shubert, CR., Bergquist, JR., Groeschl, RT., et al.[2017]

Neoadjuvant chemotherapy, given before surgery, is safe and effective for patients with resectable pancreatic cancer, potentially improving their nutritional status and leading to a median survival of 26.5 months, as shown in a recent phase II trial.

The NEOPAC phase III trial will compare the efficacy of neoadjuvant chemotherapy followed by surgery against surgery followed by adjuvant chemotherapy, with a primary focus on progression-free survival in 310 patients, aiming to provide valuable insights into treatment outcomes for pancreatic cancer.

NCBI (Pubmed)

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). Heinrich, S., Pestalozzi, B., Lesurtel, M., et al.[2022]

In a study of 120 patients with pancreatic adenocarcinoma, neoadjuvant FOLFIRINOX treatment led to a higher rate of surgical resection (66.3%) compared to gemcitabine/abraxane (32.4%), suggesting it may facilitate surgery for borderline resectable cases.

FOLFIRINOX was associated with improved progression-free survival (15.3 months) compared to gemcitabine/abraxane (8.2 months), but there was no significant difference in overall survival between the two treatments, indicating that while FOLFIRINOX may help patients live longer without disease progression, it does not necessarily extend overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative and Survival Outcomes Following Neoadjuvant FOLFIRINOX versus Gemcitabine Abraxane in Patients with Pancreatic Adenocarcinoma. Chapman, BC., Gleisner, A., Rigg, D., et al.[2022]

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 102 patients with locally advanced pancreatic cancer, chemoradiotherapy using S-1 alone showed better long-term survival rates compared to induction chemotherapy with gemcitabine followed by chemoradiotherapy, with a 2-year survival rate of 36.9% for S-1 versus 18.9% for gemcitabine.

While the initial survival probability was higher in the induction chemotherapy group during the first year, the overall survival trend favored the chemoradiotherapy alone group in the long term, indicating that induction chemotherapy may not provide lasting benefits.

NCBI (Pubmed)

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. Ioka, T., Furuse, J., Fukutomi, A., et al.[2022]

Neoadjuvant chemotherapy using S-1 and gemcitabine significantly improves survival rates for patients with resectable pancreatic cancer compared to immediate surgery, while maintaining similar perioperative outcomes.

Japanese guidelines now recommend neoadjuvant chemotherapy for resectable pancreatic cancer due to its ability to increase R0 resection rates, although identifying predictive markers for chemotherapy response is crucial to avoid missing surgical opportunities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

Recent clinical trials have provided new insights into the effectiveness of neoadjuvant chemotherapy for patients with resectable pancreatic cancer, which has been a debated topic in the medical community.

The review highlights the importance of these trials in contributing to the understanding of preoperative therapy's role in improving outcomes for patients with technically resectable pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]