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

23 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. 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.

What data supports the effectiveness of MR-guided radiation therapy combined with chemotherapy for pancreatic cancer?

Research shows that MR-guided radiation therapy can improve the precision of targeting pancreatic tumors while protecting nearby healthy organs. This approach allows for daily adjustments to the treatment plan, which can enhance the effectiveness of radiation therapy for pancreatic cancer. ^{1 2 3 4 5}

Is MR-guided radiation therapy safe for pancreatic cancer patients?

Research shows that MR-guided radiation therapy (MRgRT) is being studied for its safety in treating pancreatic cancer. Studies have evaluated its use in inoperable and locally advanced pancreatic cancer, focusing on safely increasing radiation doses while protecting normal tissues. ^{1 6 7 8 9}

How is MR-Guided Radiation Therapy different from other treatments for pancreatic cancer?

MR-Guided Radiation Therapy for pancreatic cancer is unique because it uses real-time MRI to precisely target the tumor while sparing nearby healthy organs. This allows for daily adjustments to the treatment plan, potentially improving effectiveness and reducing side effects compared to traditional radiation therapy. ^{1 2 7 9 10}

What is the purpose of this trial?

This research study is for people who have pancreas cancer for which surgery is not recommended. Potential patients must have already received several months of chemotherapy before they are eligible for this study and there will not have been any detectable spread of their tumor on imaging studies following this chemotherapy course.

Research Team

Beth Erickson, MD

Principal Investigator

Froedtert & The Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Identification of patients with locally advanced pancreatic cancer benefitting from plan adaptation in MR-guided radiation therapy. [2020]

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

Dosimetric Benefits and Practical Pitfalls of Daily Online Adaptive MRI-Guided Stereotactic Radiation Therapy for Pancreatic Cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

On-line adaptive MR guided radiotherapy for locally advanced pancreatic cancer: Clinical and dosimetric considerations. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical outcomes after online adaptive MR-guided stereotactic body radiotherapy for pancreatic tumors on a 1.5 T MR-linac. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging (MRI) compared with computed tomography (CT) for interobserver agreement of gross tumor volume delineation in pancreatic cancer: a multi-institutional contouring study on behalf of the AIRO group for gastrointestinal cancers. [2019]

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

Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. [2021]

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

A Multi-Institutional Phase 2 Trial of Ablative 5-Fraction Stereotactic Magnetic Resonance-Guided On-Table Adaptive Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Optimization of treatment planning workflow and tumor coverage during daily adaptive magnetic resonance image guided radiation therapy (MR-IGRT) of pancreatic cancer. [2022]

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

Dosimetry impact of distinct gating strategies in cine MR image-guided breath-hold pancreatic cancer radiotherapy. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

Fast and robust online adaptive planning in stereotactic MR-guided adaptive radiation therapy (SMART) for pancreatic cancer. [2022]