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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to guide chemotherapy for pancreatic cancer using a special imaging technique called DCE-MRI. The goal is to determine if this approach more effectively shrinks tumors that are hard to remove, making surgery possible. It focuses on patients with newly diagnosed borderline resectable pancreatic cancer, where tumors are difficult but not impossible to remove. Patients who have not yet received treatment for their cancer may qualify. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that the DCE-MRI imaging method is safe for guiding chemotherapy?

Research shows that administering chemotherapy before surgery, known as neoadjuvant chemotherapy, is generally safe for patients with borderline-resectable pancreatic cancer. Studies have found that this treatment can extend patients' lives by shrinking tumors before surgery. While effectiveness is often the focus, safety remains crucial.

Patients have reported tolerating this treatment well. Although exact numbers on side effects are not available from the sources, chemotherapy commonly causes side effects like nausea or fatigue. However, medical intervention can usually manage these effects.

For those considering joining a trial, it's important to know that neoadjuvant chemotherapy is not a new treatment. It has been used and studied extensively, providing doctors with experience in managing potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using imaging-guided chemotherapy for pancreatic cancer because it offers a more targeted approach to treatment. Unlike standard chemotherapy, which is often systemic and can affect the entire body, imaging-guided chemotherapy uses advanced imaging techniques to directly target the tumor. This precision can potentially increase the effectiveness of the chemotherapy while reducing side effects. Additionally, this method could help determine how well the tumor is responding to treatment early on, allowing for more personalized and adaptive treatment plans.

What evidence suggests that this imaging-guided chemotherapy could be effective for pancreatic cancer?

Research has shown that chemotherapy given before surgery, known as neoadjuvant chemotherapy, can benefit patients with pancreatic cancer that is difficult to remove. Some studies found it helped patients live longer. About 64% of patients who received this treatment underwent surgery to attempt tumor removal. These patients also had a better chance of having the entire tumor removed without any cancer cells left at the edges. This trial will evaluate the effectiveness of neoadjuvant chemotherapy for patients with borderline-resectable pancreatic cancer (BRPC), aiming to shrink tumors and make them easier to remove, potentially leading to better outcomes for patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Harrison Kim, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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, 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]

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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932015/

Neoadjuvant treatment versus upfront surgery in borderline ... Neoadjuvant treatment improved overall survival for borderline-resectable pancreatic cancer (HR 0.60, 95% ci 0.38 to 0.96) but not resectable pancreatic cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6329638/

Outcome of Patients with Borderline Resectable Pancreatic ... 31.1% of patients with BRPC have progression of disease during neoadjuvant therapy. The remaining 63.6% of patients with BRPC undergo surgical resection.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666262022000778

Neoadjuvant chemotherapy improves outcomes in ... NAC appears to be associated with a survival benefit for patients with resectable PDAC. NAC also decreased the risk of a positive resection margin and positive ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.5523

Neoadjuvant chemotherapy and radiotherapy outcomes in ... BRPC and LAPC patients capable of surgery after only receiving neoadjuvant treatment with chemotherapy had higher rates of R0 resection with ...

5. redjournal.org redjournal.org/article/S0360-3016(25)00175-0/fulltext

Role of Neoadjuvant Chemoradiation Therapy for ... Randomized trials and meta-analyses have indicated longer survival with neoadjuvant than with adjuvant therapy in patients with resectable or borderline ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X2030006X

Neoadjuvant chemotherapy for primary resectable ... Long-term outcome following neoadjuvant therapy for resectable and borderline resectable pancreatic cancer compared to upfront surgery: a meta-analysis of ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.704

Does neoadjuvant treatment in resectable pancreatic ... This metanalysis of six randomized controlled trials suggests that neoadjuvant chemotherapy with gemcitabine-based regimens does not improve PFS or OS in RPC.

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06944106

NCT06944106 | A Study on Ivonescimab Plus ... This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the ...

9. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.01461/full

Outcomes of Neoadjuvant Chemoradiation With and ... In borderline resectable pancreatic carcinoma, 50% of patients treated with chemoradiation alone achieved 1 year recurrence free survival ...