MR-Guided Radiation Therapy for Stomach Cancer

Recruiting at 1 trial location

Overseen By Hyun Kim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Investigational agents, Strong CYP3A4 inhibitors

Disqualifiers: Prior surgery, Active malignancy, Uncontrolled illness, 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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

4 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents, and certain ART medications may be excluded due to drug interactions. It's best to discuss your current medications with the trial team.

What data supports the idea that MR-Guided Radiation Therapy for Stomach Cancer is an effective treatment?

The available research shows that MR-Guided Radiation Therapy can effectively target stomach cancer while minimizing damage to surrounding healthy tissue. This is particularly important for stomach cancer, as the stomach moves a lot due to breathing and food intake. One case report highlighted a patient with recurrent stomach cancer who couldn't undergo surgery or chemotherapy but benefited from this treatment. Although specific data for stomach cancer is limited, studies on other cancers, like pancreatic cancer, show that MR-Guided Radiation Therapy can improve treatment precision and protect healthy organs. This suggests it could be a promising option for stomach cancer as well. ^{1 2 3 4 5}

What safety data exists for MR-guided radiation therapy for stomach cancer?

The safety data for MR-guided radiation therapy includes a failure modes and effects analysis for system safety, as mentioned in the development of an MRgRT system. A case report highlights the use of real-time MRI-guided adaptive treatment for a patient with recurrent gastric cancer, suggesting its potential to minimize radiation exposure to normal tissues. Additionally, a 4.5-year clinical experience with MRIgRT indicates its safe implementation with improved imaging and adaptive capabilities. Early clinical results also demonstrate the feasibility of safe delivery in treating oligometastatic disease. ^{1 6 7 8 9}

Is MR-guided radiation therapy a promising treatment for stomach cancer?

Yes, MR-guided radiation therapy is promising for stomach cancer because it can accurately target the cancer while protecting healthy tissue. It adapts to changes in the stomach's shape caused by breathing and eating, making it more effective than traditional methods. ^{1 2 10 11 12}

What is the purpose of this trial?

Gastric cancer is a global health issue as the world's fifth most common malignancy and third leading cause of cancer mortality, respectively. Preoperative radiation therapy may improve overall survival (OS) but is seldom used. There is precedent for preoperative chemoradiation, as it is the standard of care for esophageal and gastroesophageal junction tumors. However, reluctance of physicians to prescribe preoperative radiation therapy in gastric cancer may be due to the large treatment fields necessary to account for stomach motion. Adaptive radiation therapy may permit decreased field sizes and more accurate dose delivery. In traditional CT based radiation delivery the same radiation plan is delivered each day without assessment of inter-fraction or intra-fraction motion. Adaptive radiation therapy permits the physician to contour the unique anatomy daily to generate a new plan to account for day to day organ motion. Real-time MR imaging is also used during the treatment so that radiation is only delivered when the tumor is within the pre-specified target area. Thus, adaptive radiation therapy may overcome traditional barriers of radiation delivery in gastric cancer and improve oncologic outcomes.

Research Team

Hyun Kim

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 19 with newly diagnosed gastric adenocarcinoma, specifically stages I-III without metastatic disease. Participants must have normal organ and bone marrow function, agree to use contraception, and not be pregnant or breastfeeding. They can't join if they've had prior treatments for gastric cancer, certain other cancers within the last two years, contraindications to MRI, or uncontrolled illnesses.

Inclusion Criteria

Hemoglobin > 9 g/dL

My doctor says I can have CAPOX chemotherapy.

Absolute neutrophil count ≥ 1,500 cells/mm3

Exclusion Criteria

Contraindications to MRI (e.g., non-compatible implantable device or metallic foreign bodies).

You are currently taking any experimental medications that are not approved by regulatory authorities.

I have had surgery on my esophagus or stomach.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive adaptive short course radiation therapy (25 Gy in 5 fractions)

1 week

Chemotherapy

Participants receive standard of care total neoadjuvant chemotherapy (e.g., CAPOX, FOLFOX, or FLOT)

Approximately 3 months

Surgery

Participants undergo standard of care gastrectomy or esophagogastrectomy

At the time of surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year post radiation

Treatment Details

Interventions

• MR guided radiation therapy

Trial Overview The study tests MR-guided radiation therapy (MRgRT) alongside standard chemotherapy in treating stomach cancer. MRgRT aims to deliver more accurate radiation doses by accounting for daily organ motion and only targeting the tumor when it's correctly positioned.

Participant Groups

Group I: Pre-operative adaptive short course radiation therapy Experimental Treatment 2 Interventions

Consenting and eligible patients will receive adaptive short course radiation therapy (SCRT) (25 Gy at in 5 fractions), followed by standard of care total neoadjuvant chemotherapy followed by standard of care gastrectomy or esophagogastrectomy. The recommended SOC chemotherapy options are CAPOX, FOLFOX, or FLOT, but any SOC total neoadjuvant chemotherapy may be given at the discretion of the treating medical oncologist after consultation with the study chair. Patients who are not able to complete their full total neoadjuvant therapy regimen prior to surgery may complete chemotherapy postoperatively at the discretion of the treating physician.

MR guided radiation therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as MR-guided radiation therapy for:

• Gastric cancer
• Esophageal cancer
• Gastroesophageal junction tumors

Approved in United States as MR-guided radiation therapy for:

• Gastric cancer
• Esophageal cancer
• Gastroesophageal junction tumors

Approved in Canada as MR-guided radiation therapy for:

• Gastric cancer
• Esophageal cancer
• Gastroesophageal junction tumors

Approved in Japan as MR-guided radiation therapy for:

• Gastric cancer
• Esophageal cancer
• Gastroesophageal junction tumors

Approved in China as MR-guided radiation therapy for:

• Gastric cancer
• Esophageal cancer
• Gastroesophageal junction tumors

Approved in Switzerland as MR-guided radiation therapy for:

• Gastric cancer
• Esophageal cancer
• Gastroesophageal junction tumors

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Viewray Inc.

Industry Sponsor

Trials

13

Recruited

1,100+

Findings from Research

Real-time magnetic resonance (MR)-guided radiotherapy allows for precise targeting of high-dose radiation to the stomach, minimizing exposure to surrounding healthy tissues, which is crucial for patients with deforming organs like the stomach.

In a case report of a patient with recurrent gastric cancer who could not undergo surgery or chemotherapy, MR-guided adaptive radiotherapy was successfully applied, showcasing its potential as a viable treatment option for complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Report of Salvage Radiotherapy for a Patient with Recurrent Gastric Cancer and Multiple Comorbidities Using Real-time MRI-guided Adaptive Treatment System. Chun, SJ., Jeon, SH., Chie, EK.[2020]

Magnetic resonance imaging (MRI)-guided adaptive radiotherapy enhances the precision of radiation treatment by providing real-time anatomical and functional imaging during therapy sessions.

This advanced imaging technique could lead to improved treatment outcomes by allowing for adjustments in radiation delivery based on the patient's changing anatomy throughout the course of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided adaptive radiotherapy: a solution to the future. Kupelian, P., Sonke, JJ.[2022]

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]

The first clinical implementation of online adaptive magnetic resonance image-guided radiation therapy (MR-IGRT) was successfully conducted on 5 patients with abdominopelvic cancers, demonstrating the feasibility of real-time adaptive planning during treatment.

Out of 170 treatment fractions in an expanded cohort, 30.6% required online reoptimization, indicating that adapting treatment plans based on daily imaging can effectively address changes in tumor size and patient anatomy, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. Acharya, S., Fischer-Valuck, BW., Kashani, R., et al.[2022]

Online adaptive magnetic resonance image guided radiotherapy (MRgRT) was well-tolerated in a study of 15 pediatric and young adult patients, with no unexpected toxicity reported, indicating its safety for this population.

MRgRT provided dosimetric advantages for tumors located near critical structures, allowing for more precise treatment while minimizing damage to surrounding healthy tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical applications treating pediatric and adolescent patients using MR-guided radiotherapy. Kozak, MM., Crompton, D., Gross, BA., et al.[2023]

The development of an online Magnetic Resonance guided Radiation Therapy (MRgRT) system aims to enhance safety by providing real-time MRI images before radiation treatment, allowing for better image guidance.

A thorough failure modes and effects analysis identified potential risks during the design and operation of the MRgRT system, leading to design improvements and safety measures before installation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poster - Thur Eve - 05: Safety systems and failure modes and effects analysis for a magnetic resonance image guided radiation therapy system. Lamey, M., Carlone, M., Alasti, H., et al.[2019]

A new software workflow for real-time dose estimation in MR-guided radiotherapy was developed and successfully tested on three prostate cancer patients, showing negligible differences between online and offline dose reconstructions.

The system demonstrated high accuracy with a median gamma pass rate of 100% for the planning target volume, allowing for effective online adaptive treatment decisions based on real-time data during radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time motion-including dose estimation of simulated multi-leaf collimator-tracked magnetic resonance-guided radiotherapy. Persson, E., Goodwin, E., Eiben, B., et al.[2023]

MRI-guided radiotherapy (MRIgRT) has been effectively used in treating 642 patients over 4.5 years, with breast and gastrointestinal cancers being the most common indications, showcasing its broad applicability in radiation oncology.

Adaptive radiotherapy (ART) was utilized in 190 patients, with a significant 67.6% of treatment fractions being adapted, particularly for abdominal cancers, indicating the technology's ability to adjust treatment based on real-time anatomical changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. Henke, LE., Contreras, JA., Green, OL., et al.[2023]

Magnetic Resonance-guided Radiation Therapy (MRgRT) shows promise for safely delivering high doses of radiation to oligometastatic tumors while protecting surrounding healthy tissues, thanks to its superior imaging capabilities and real-time monitoring.

Despite its potential, further clinical evidence is needed to address technical challenges and ensure safety in the MRI environment, highlighting the importance of ongoing research in this innovative treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided Radiotherapy (MRgRT) for Treatment of Oligometastases: Review of Clinical Applications and Challenges. Chetty, IJ., Doemer, AJ., Dolan, JL., et al.[2022]

The use of magnetic resonance imaging guided radiotherapy (MRgRT) with a hybrid MR-LINAC system allows for adaptive treatment plans that can adjust to the stomach's changing shape during treatment, which is crucial for effectively targeting gastric cancer.

In a case study of a 58-year-old male with stage IV gastric cancer, daily adaptive radiotherapy was implemented, showing promise for improving treatment accuracy and outcomes for patients with inoperable upper abdominal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: MR-LINAC-guided adaptive radiotherapy for gastric cancer. Song, Y., Zhang, Y., Wang, H., et al.[2023]

Magnetic resonance imaging (MR) is becoming increasingly important in radiation oncology for planning and delivering radiotherapy, enhancing the precision of treatment.

The review highlights both the advantages and challenges of integrating MR technology with radiation therapy, including the need for specialized equipment and systems to accurately estimate electron density from MR images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance image guidance in external beam radiation therapy planning and delivery. Arivarasan, I., Anuradha, C., Subramanian, S., et al.[2018]

The first commercially available MRI-guided radiation therapy system combines a 0.35-T MR scanner with three radiation heads, allowing for simultaneous imaging and treatment, which enhances precision in targeting tumors.

This system enables rapid adaptive treatment planning and control based on real-time visualization of soft tissues, improving the efficacy and safety of radiation therapy since its use began in January 2014.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ViewRay system: magnetic resonance-guided and controlled radiotherapy. Mutic, S., Dempsey, JF.[2022]

References

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

A Case Report of Salvage Radiotherapy for a Patient with Recurrent Gastric Cancer and Multiple Comorbidities Using Real-time MRI-guided Adaptive Treatment System. [2020]

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

Magnetic resonance-guided adaptive radiotherapy: a solution to the future. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Initial clinical applications treating pediatric and adolescent patients using MR-guided radiotherapy. [2023]

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

Poster - Thur Eve - 05: Safety systems and failure modes and effects analysis for a magnetic resonance image guided radiation therapy system. [2019]

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

Real-time motion-including dose estimation of simulated multi-leaf collimator-tracked magnetic resonance-guided radiotherapy. [2023]

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

Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. [2023]

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

MRI-guided Radiotherapy (MRgRT) for Treatment of Oligometastases: Review of Clinical Applications and Challenges. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: MR-LINAC-guided adaptive radiotherapy for gastric cancer. [2023]

11. Japan pubmed.ncbi.nlm.nih.gov

Magnetic resonance image guidance in external beam radiation therapy planning and delivery. [2018]

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

The ViewRay system: magnetic resonance-guided and controlled radiotherapy. [2022]