MRI + CT-Guided Radiation Therapy for Sarcoma

Overseen By Vincent Basehart

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Active malignancy treatment, Prior irradiation

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 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Recent advances in radiation treatment have allowed for higher doses per treatment to be delivered safely. This study plans to use an MRI-guided linear accelerator to deliver the radiation treatment to ensure that the radiation dose is administered to the cancerous tumor, not the vital body organs. Potential participants with a sarcoma diagnosis will be referred to Radiation Oncology during this study. If the participant is interested in participating in this study, s/he receives radiation treatment daily for 5 consecutive days except for weekends and holidays. Within 12 weeks of completing the radiation therapy, the participant will have the primary tumor surgically removed. The radiation oncology team will follow the patients for 5 years after completing radiation therapy.

Do I need to stop my current medications for the trial?

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 data supports the effectiveness of the treatment MRI + CT-Guided Radiation Therapy for Sarcoma?

Research shows that MRI-guided radiation therapy can safely and effectively target tumors in various parts of the body, such as the spine and liver, by providing clear images that help protect healthy tissues while focusing on the tumor. ^{1 2 3 4 5}

Is MRI + CT-guided radiation therapy generally safe for humans?

Research on MRI and CT-guided radiation therapy, particularly for liver and prostate tumors, suggests it is generally safe with mild side effects like nausea, vomiting, and abdominal pain. However, further studies are needed to fully understand the benefits and risks. ^{2 6 7 8 9}

What makes MRI + CT-guided radiation therapy for sarcoma unique compared to other treatments?

This treatment is unique because it combines MRI and CT imaging to precisely guide radiation therapy, allowing for accurate targeting of the tumor while sparing healthy tissue. The use of MRI provides clear visualization of the tumor and surrounding structures, which can improve the precision and safety of the treatment compared to traditional methods. ^{1 2 3 4 10}

Eligibility Criteria

This trial is for individuals with a diagnosis of sarcoma, specifically in the abdominopelvic region. Participants will undergo radiation therapy daily for 5 days and have their primary tumor surgically removed within 12 weeks after completing radiation. They'll be followed up for 5 years.

Inclusion Criteria

I am mostly able to care for myself and remain active.

I am 12 years old or older.

If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented

Exclusion Criteria

I am currently being treated for another cancer.

I have had radiation therapy on the area that needs treatment now.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive MRI or CT-guided stereotactic body radiation therapy daily for 5 consecutive days, except weekends and holidays

1 week

5 visits (in-person)

Surgery

Surgical resection of the primary tumor is performed within 12 weeks of completing radiation therapy

Up to 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up by the radiation oncology team for 5 years

5 years

Treatment Details

Interventions

• Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy

Trial Overview The study tests MRI and CT-guided stereotactic body radiation therapy to target cancerous tumors precisely while sparing vital organs. The goal is to deliver higher doses safely over a short period (5 consecutive days).

Participant Groups

Group I: Arm I Experimental Treatment 1 Intervention

MRI or CT-guided SBRT will be delivered in the pre-operative setting. Patients will receive 5.0-6.0 Gy x 5 fractions delivered daily.

Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Soft tissue sarcoma
• Lung cancer
• Pancreatic cancer
• Liver cancer
• Spinal tumors

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Soft tissue sarcoma
• Lung cancer
• Pancreatic cancer
• Liver cancer
• Spinal tumors

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Soft tissue sarcoma
• Lung cancer
• Pancreatic cancer
• Liver cancer
• Spinal tumors

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Findings from Research

MRI-guided radiotherapy (MRI-RT) for spinal metastases is feasible using Co-60 technology, with successful treatment delivery and no observed toxicities in nine cases.

Switching to newer linear accelerator (linac) MRI-RT improves dose delivery and reduces dose spillage into surrounding tissues, enhancing the safety and efficacy of spinal stereotactic ablative radiotherapy (SABR).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided stereotactic ablative radiation therapy of spinal bone metastases: a preliminary experience. Llorente, R., Spieler, BO., Victoria, J., et al.[2022]

In a study of 26 patients with liver tumors treated using MR-guided stereotactic body radiation therapy (SBRT), no severe gastrointestinal toxicities (grade 4 or higher) were observed, indicating a high safety profile for this treatment approach.

The treatment demonstrated excellent local control with an 80.4% freedom from local progression at a median follow-up of 21.2 months, suggesting that MR guidance allows for effective targeting of tumors while sparing healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multi-Institutional Experience of MR-Guided Liver Stereotactic Body Radiation Therapy. Rosenberg, SA., Henke, LE., Shaverdian, N., et al.[2022]

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 MRI-guided stereotactic body radiation therapy (SBRT) allows for better dose escalation to tumors while simultaneously protecting surrounding organs at risk (OARs), as shown in a study of 10 patients with oligometastatic disease.

The adaptive planning improved planning target volume (PTV) coverage in 21 out of 30 cases, demonstrating its potential to enhance treatment effectiveness compared to traditional nonadaptive SBRT methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulated Online Adaptive Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Oligometastatic Disease of the Abdomen and Central Thorax: Characterization of Potential Advantages. Henke, L., Kashani, R., Yang, D., et al.[2022]

The study demonstrated that online adaptive MR-guided stereotactic body radiation therapy (SBRT) is feasible and well-tolerated in 25 patients with unresectable upper abdominal tumors, with 84% of treatment fractions completed within 60 minutes.

No severe acute toxicity (grade 3 or higher) was reported, and the treatment successfully alleviated pain in 11 out of 13 patients, indicating both safety and efficacy in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. Daamen, LA., de Mol van Otterloo, SR., van Goor, IWJM., et al.[2022]

In a study of 3410 patients treated with SBRT for localized prostate cancer, only 4.75% received treatment planning using CT alone, and this group showed tolerable toxicity with only two cases of Grade 3+ toxicity reported.

Quality of life assessments indicated temporary declines in urinary and bowel function after treatment in the CT group, but these returned to baseline levels in follow-up, suggesting that CT-based planning is a safe alternative for patients who cannot undergo MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of stereotactic body radiation therapy for localized prostate cancer without treatment planning MRI. Amarell, K., Jaysing, A., Mendez, C., et al.[2022]

In a study involving 10 patients with liver metastases, MR-guided stereotactic body radiotherapy (MRgSBRT) demonstrated excellent visibility of tumors without the need for fiducial markers, indicating a promising non-invasive treatment option.

The treatment was well-accepted by patients, with no reported cases of symptomatic radiation-induced liver disease after a median follow-up of 10 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance. Gani, C., Boeke, S., McNair, H., et al.[2022]

In a study involving 56 patients treated with Magnetic Resonance guided Radiotherapy (MRgRT) for primary liver tumors, no severe toxicities (greater than CTCAE grade 2) were observed, indicating a high safety profile for this treatment.

MRgRT achieved excellent local control rates of 98.1% at 12 months and 94.7% at 18 months, with an overall survival rate of 85.1% at 1 year, demonstrating its efficacy in managing primary liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. Bordeau, K., Michalet, M., Dorion, V., et al.[2023]

Stereotactic body radiation therapy (SBRT) using an MR-linac platform was successfully administered to 29 patients with minimal treatment delays, showing effective tumor response with most lesions either stable or reduced in size after treatment.

The use of MRI for real-time image guidance in SBRT resulted in lower liver doses and reduced toxicities, suggesting a safer treatment option for patients with hepatic tumors, although further studies are needed to fully assess the benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time Magnetic Resonance-guided Liver Stereotactic Body Radiation Therapy: An Institutional Report Using a Magnetic Resonance-Linac System. Feldman, AM., Modh, A., Glide-Hurst, C., et al.[2023]

The study demonstrated that a one-stop-shop (OSS) procedure for MR-guided Stereotactic Ablative Radiotherapy (SABR) in lung cancer patients is feasible, with all 10 participants completing the treatment in a single day and reporting high satisfaction levels.

The accuracy of the treatment delivery was high, with the tracking system covering 78% to 100% of the tumor volume during radiation, indicating effective real-time monitoring and minimal impact from system latency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-day consultation, simulation and lung Stereotactic Ablative Radiotherapy delivery on a Magnetic Resonance-linac. Palacios, MA., Verheijen, S., Schneiders, FL., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

MRI-guided stereotactic ablative radiation therapy of spinal bone metastases: a preliminary experience. [2022]

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

A Multi-Institutional Experience of MR-Guided Liver Stereotactic Body Radiation Therapy. [2022]

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

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

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

Simulated Online Adaptive Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Oligometastatic Disease of the Abdomen and Central Thorax: Characterization of Potential Advantages. [2022]

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

Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of stereotactic body radiation therapy for localized prostate cancer without treatment planning MRI. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. [2023]

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

Real-time Magnetic Resonance-guided Liver Stereotactic Body Radiation Therapy: An Institutional Report Using a Magnetic Resonance-Linac System. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Same-day consultation, simulation and lung Stereotactic Ablative Radiotherapy delivery on a Magnetic Resonance-linac. [2022]