MR-Guided Radiation Therapy for Stomach Cancer

No longer recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new radiation therapy technique guided by MRI to treat stomach cancer. The goal is to enhance precision by adjusting the treatment daily to match the tumor's position, potentially leading to better outcomes. It targets individuals newly diagnosed with stomach cancer that hasn't spread extensively. Participants should not have received previous cancer treatments for the stomach or esophagus. This method, known as MR-guided radiation therapy, could improve the effectiveness of radiation targeting the cancer, making it a promising option for eligible patients. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a promising opportunity for eligible patients to benefit from innovative therapy.

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 prior data suggests that MR-guided radiation therapy is safe for stomach cancer?

Studies have shown that MR-guided radiation therapy is generally well-tolerated by patients. Research indicates that this method allows precise targeting of cancer, potentially leading to fewer side effects compared to traditional radiation. In a report on using MR-guided radiation for stomach cancer, few severe stomach or intestinal side effects were reported, suggesting the treatment is safe for most people.

Overall, available data suggests that MR-guided radiation therapy is safe, with few serious side effects reported. This information is based on earlier studies and the current phase of the trial, which aims to further understand its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about MR-guided radiation therapy for stomach cancer because it offers a more precise and adaptable approach compared to traditional radiation treatments. Unlike conventional methods, this technique uses real-time magnetic resonance imaging (MRI) to guide radiation delivery, allowing for adjustments during treatment to better target tumors while sparing healthy tissue. This could potentially enhance the effectiveness of radiation therapy and reduce side effects, making it a promising option for patients. Additionally, the short course of radiation (only five sessions) before surgery and chemotherapy could lead to quicker recovery and improved outcomes.

What evidence suggests that MR-guided radiation therapy is effective for stomach cancer?

This trial will evaluate MR-guided radiation therapy as a pre-operative treatment for stomach cancer. Studies have shown that MR-guided radiation therapy is a promising treatment for this condition. This method uses real-time MRI scans to deliver radiation precisely, targeting the tumor more accurately and potentially reducing harm to nearby healthy tissue. Research suggests that this flexible approach could improve treatment outcomes by adjusting for the stomach's movement, a challenge with traditional radiation therapy. Early findings indicate that MR-guided therapy may better control the tumor and potentially improve survival rates. This innovative technique represents a significant advancement in cancer treatment, especially for challenging cases like stomach cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Hyun Kim

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

I can take care of myself but might not be able to do heavy physical work.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10514477/

MR-LINAC-guided adaptive radiotherapy for gastric cancer

In this case report, we present our clinical experience to treat a gastric cancer patient using MR-LINAC.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1053429623000681

MRI-Guided Adaptive Radiation Therapy

MRIgRT has improved image-guided radiation therapy by providing superior image quality compared to CBCT, intrafraction visualization of internal structures, ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37746250/

MR-LINAC-guided adaptive radiotherapy for gastric cancer

Online adaptive MRgRT can be a meaningful innovation for treating malignancies in the upper abdomen. The results in the current study are ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S105342962300070X

Articles The Future of MR-Guided Radiation Therapy

Daily image-guided radiotherapy for patients with prostate cancer reduced the risk of late rectal toxicity by 30% and simultaneously reduced the risk of ...

5.

aapm.org

aapm.org/meetings/2017AM//PRAbs.asp?mid=127&aid=38033

Meeting Program - Abstract Information

Purpose: Magnetic resonance guided radiation therapy (MRgRT) is being utilized for gating treatments based on real-time target tracking. In this study, we ...

6.

withpower.com

withpower.com/trial/phase-stomach-neoplasms-1-2020-9fddb

MR-Guided Radiation Therapy for Stomach Cancer

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 ...

7.

pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/radiol.2020202747

MRI-guided Radiation Therapy: An Emerging Paradigm in ...

This review describes emerging innovations in offline and online MRI-guided RT, exciting opportunities they offer for advancing research and clinical care.

8.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(23)09371-4/fulltext

Stereotactic MR-guided on-table adaptive radiation therapy ...

Long-term outcomes include 2-year overall survival from diagnosis and SMART of 53.6 % and 40.5 %, respectively, and minimal late grade ≥ 3 GI ...