MR-Guided Radiation + Chemotherapy for Pancreatic Cancer

Overseen By Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Must be taking: Chemotherapy

Disqualifiers: Metastatic disease, Second malignancy, AIDS, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment that combines Magnetic Resonance Guided Radiation Therapy with chemotherapy for pancreatic cancer. It aims to determine if this approach can better target tumors in individuals whose cancer cannot be surgically removed but has not spread. The trial seeks participants who have undergone several months of chemotherapy without cancer progression. This study may suit those with locally advanced pancreatic cancer who have not had surgery and are interested in a combined radiation and chemotherapy approach. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since participants must have had at least 4 months of prior chemotherapy, it is likely that continuing some form of treatment is expected. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Magnetic Resonance Guided Radiation Therapy (MRgRT) is generally safe for treating pancreatic cancer. Studies have found that this type of radiation therapy carries a low risk of serious side effects, so patients usually do not experience severe reactions.

The study includes chemotherapy with either Gemcitabine or Capecitabine. Gemcitabine, a common drug for pancreatic cancer, is considered safe and effective, often being well-tolerated by patients. Similarly, Capecitabine is reported to be safe and beneficial for cancer patients.

Overall, previous research indicates that these treatments are likely safe and well-tolerated, with a low chance of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Magnetic Resonance Guided Radiation Therapy combined with chemotherapy for pancreatic cancer because it offers a more precise approach to targeting tumors. Unlike conventional radiation therapy, which can affect surrounding healthy tissues, this method uses MR imaging to accurately direct higher doses of radiation specifically to the cancerous area, potentially increasing effectiveness while minimizing side effects. Additionally, the ability to escalate radiation doses and pair them with chemotherapy drugs like Gemcitabine or Capecitabine could improve outcomes for patients with unresectable non-metastatic pancreatic cancer, a group for whom traditional treatments offer limited benefits.

What evidence suggests that MR-guided radiation therapy plus chemotherapy could be effective for pancreatic cancer?

This trial will evaluate the combination of Magnetic Resonance Guided Radiation Therapy (MRgRT) with chemotherapy for pancreatic cancer. Research has shown that MRgRT can lead to positive outcomes. In one study, 85% of patients did not experience cancer worsening over two years. Another study found that 53.6% of patients were still alive two years after diagnosis, suggesting a potential for longer life.

Participants in this trial will receive MRgRT alongside either Gemcitabine or Capecitabine. Gemcitabine has been shown to help patients live longer and is generally well-tolerated, with studies indicating that 18% of patients survived for 12 months. Capecitabine demonstrated that 77.8% of patients experienced no cancer progression during treatment. Together, these treatments offer hope for those with pancreatic cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Beth Erickson, MD

Principal Investigator

Froedtert & The Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic cancer that can't be removed by surgery. They should have completed at least 4 months of chemotherapy without the cancer spreading, as confirmed by imaging. Participants need to be able to swallow pills and use effective contraception if applicable.

Inclusion Criteria

I am using effective birth control methods.

My pancreatic cancer is advanced and cannot be removed with surgery.

I may or may not have swollen lymph nodes.

Exclusion Criteria

Participation in another clinical treatment trial while on study

My cancer has spread to distant parts of my body, or I have another type of cancer or cancer spread in the abdomen.

I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive full dose chemotherapy prior to radiation therapy

Several months

Radiation

Participants receive MR guided dose escalated radiation therapy with concurrent chemotherapy

Up to 7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• Gemcitabine
• Magnetic Resonance Guided Radiation Therapy

Trial Overview The study tests a combination of dose-escalated radiation therapy guided by magnetic resonance (MR) imaging alongside concurrent chemotherapy drugs Gemcitabine and Capecitabine in patients who are not candidates for surgical treatment of their pancreatic cancer.

How Is the Trial Designed?

Group I: Radiation therapy plus chemotherapy Experimental Treatment 2 Interventions

MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

In a study of 36 patients with locally advanced pancreatic cancer, daily plan adaptation during MR-guided radiation therapy significantly improved target coverage and reduced high doses to nearby organs at risk, with compliance to institutional constraints increasing from 43.9% to 83.3%.

Adaptive planning was beneficial in about 52.8% of treatment fractions, particularly when the distance from the tumor to adjacent organs at risk was 3 mm or less, highlighting the importance of personalized treatment approaches in radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of patients with locally advanced pancreatic cancer benefitting from plan adaptation in MR-guided radiation therapy. Bohoudi, O., Bruynzeel, AME., Meijerink, MR., et al.[2020]

In a study of 44 patients with inoperable pancreatic cancer, those receiving high-dose MRgRT (biologically effective dose >70) showed a significant improvement in 2-year overall survival (49% vs 30%) compared to those receiving standard-dose treatment.

High-dose MRgRT was associated with lower rates of severe gastrointestinal toxicity, as no grade 3 or higher GI toxicity was reported in the high-dose group, while three patients in the standard-dose group experienced such toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Rudra, S., Jiang, N., Rosenberg, SA., et al.[2021]

The SMART3CM strategy for adaptive radiation therapy in locally advanced pancreatic cancer significantly reduces the number of required optimizations (4 vs 18) compared to the standard FULLOAR method, while maintaining equivalent target coverage (mean V95%=89%).

Using SMART3CM results in lower doses to surrounding organs at risk (OARs) and better adherence to dose constraints, demonstrating its efficacy in sparing healthy tissue during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast and robust online adaptive planning in stereotactic MR-guided adaptive radiation therapy (SMART) for pancreatic cancer. Bohoudi, O., Bruynzeel, AME., Senan, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3012429/

Capecitabine: an evidence-based review of its effectiveness in ... The median time to progression was 6 months, the median survival was 8 months, and 12-month survival was 35%. Similar results have been reported recently from ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11773165/

Phase II study of oral capecitabine in patients with ... Results: Ten (24%) of 42 patients experienced a clinical benefit response (95% confidence interval [CI], 12.1% to 39.5%) as evidenced by improvement in pain ...

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2009.27.15_suppl.e15558

Definitive chemoradiation therapy with capecitabine in ... Of the 36 evaluable patients, 15 (41.7 %) patients achieved partial response, and 13 (36.1 %) had a stable disease with 77.8% of disease control rate. Among the ...

4. gutnliver.org gutnliver.org/journal/view.html?doi=10.5009/gnl16307

Efficacy of Capecitabine Plus Oxaliplatin Combination ... The median progression-free and overall survival were 88 days (range, 35.1 to 140.9 days) and 158 days (range, 118.1 to 197.9 days), ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13799-5

Efficacy and safety of triplet regimen capecitabine ... The XELOXIRI regimen demonstrated promising efficacy and manageable toxicity in the treatment of APC, providing a practical alternative to FOLFOXIRI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11905668/

Efficacy and safety of triplet regimen capecitabine, oxaliplatin ... The 5-fuorouracil, oxaliplatin and irinotecan (FOLFOXIRI) regimen is the standard first-line treatment for advanced pancreatic cancer (APC).

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.24.01118

Long-Term Outcomes of Adjuvant Therapy in the ESPAC4 ... The ESPAC4 trial showed that adjuvant chemotherapy with gemcitabine plus capecitabine (GemCap) produced longer overall survival (OS) than gemcitabine ...

8. thelancet.com thelancet.com/article/S0140-6736(16)32409-6/fulltext

Comparison of adjuvant gemcitabine and capecitabine ... We aimed to determine the efficacy and safety of gemcitabine and capecitabine compared with gemcitabine monotherapy for resected pancreatic ...

9. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2002.20.1.160

Phase II Study of Oral Capecitabine in Patients With ... CONCLUSION: Treatment with capecitabine resulted in clinically significant beneficial effects on tumor-related symptoms and yielded objective response activity ...