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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation treatment to individuals with sarcoma, a cancer often affecting the abdomen or pelvis. Advanced imaging techniques precisely target the tumor, minimizing radiation damage to healthy organs. Participants will receive a daily radiation dose for five days, followed by surgical tumor removal within 12 weeks. The trial seeks participants diagnosed with surgically removable sarcoma who have not received prior radiation in the same area. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in sarcoma care.

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 prior data suggests that MRI and CT-guided radiation therapy is safe for treating sarcoma?

Research has shown that using MRI and CT scans to guide stereotactic body radiation therapy (SBRT) is generally safe for treating certain cancers. In studies with other types of cancer, patients have tolerated this treatment well, experiencing few serious side effects. One study found that using MRI to guide radiation therapy was feasible and caused minimal harm to the body. Another study demonstrated that SBRT for soft tissue cancers was both safe and effective.

This trial is in Phase 2, indicating that earlier studies have already shown the treatment to be somewhat safe. This phase focuses more on evaluating the treatment's effectiveness and monitoring for any side effects. Although the treatment remains under study, existing research suggests it is generally safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for sarcoma?

Most treatments for sarcoma involve surgery followed by radiation therapy or chemotherapy. However, MRI + CT-guided radiation therapy is unique because it combines advanced imaging techniques to precisely target the tumor with stereotactic body radiation therapy (SBRT). This method allows for high doses of radiation to be delivered directly to the cancer cells while minimizing damage to surrounding healthy tissues. Researchers are excited about this approach because it could potentially improve treatment outcomes by increasing the accuracy and effectiveness of radiation therapy, especially in the pre-operative setting.

What evidence suggests that MRI and CT-guided radiation therapy is effective for sarcoma?

Research has shown that using MRI and CT scans to guide stereotactic body radiation therapy (SBRT) holds promise for treating sarcomas. In this trial, participants will receive MRI or CT-guided SBRT before surgery. Studies have found SBRT effective for cancer that has spread to the lungs, with some patients experiencing long-lasting benefits. Additionally, MRI-guided radiation can prevent cancer from spreading in the treated area. Previous results suggest that SBRT is safe and effective for certain soft tissue cancers. These findings support the potential of MRI and CT-guided SBRT to precisely target tumors, reducing harm to nearby healthy tissues. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10514933/

Treatment outcomes of stereotactic body radiation therapy ... The 1-year overall survival was 80.5%, and PTV and visceral metastases were independently associated with inferior overall survival. Conclusion. SBRT for spinal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06436612?cond=Sarcoma&viewType=Table&rank=3

NCT06436612 | Study of Magnetic Resonance Image and ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10105948/

Treatment outcomes of stereotactic body radiation therapy for ... Conclusion. SBRT for pulmonary metastasis of sarcoma is effective. Some selected patients may achieve durable response. Considerations of SBRT ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S016781402500043X

1-year efficacy results after MR-guided risk-adapted ... The SOFT study provides MR-guided SABR for 121 patients with abdominal metastases. We achieved a high one-year local control rate of 89.0% using MR-guided SABR.

5. mdpi.com mdpi.com/2077-0383/11/4/1042

The Role of MRI-Guided Radiotherapy for Soft Tissue ... The role of SBRT for oligometastatic STS appears to be both safe and effective [25,26]. Hypofractionated radiation for palliation may allow for improvement of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3807836/

Safety and Efficacy of Stereotactic Body Radiation Therapy in ... Of the high-grade sarcomas (HGS), 40–60% of patients will develop lung metastases (LM), of which 70–80% will have disease limited to the lungs, likely through ...

7. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89863-2/fulltext

Efficacy and safety of SBRT for spine metastases In this study, we summarize the available evidence for stereotactic body radiotherapy (SBRT) in the treatment of spinal metastases. Materials ...

8. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01791-9

MR-guided stereotactic body radiation therapy for primary ... In the present study we evaluated the feasibility and early outcome of MR-guided RT for primary cardiac sarcomas. Toxicity was reported ...