MRI for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how MRI scans can track changes in soft tissue sarcoma during treatment. Participants will undergo three additional MRI scans while receiving standard radiation therapy (neoadjuvant radiotherapy) to assess tumor response. The trial seeks individuals with a confirmed history of soft tissue sarcoma who plan to receive radiation treatment before surgery. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment monitoring.
Do I have to stop taking 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 team or your doctor.
What prior data suggests that MRI studies at non-SOC timepoints are safe for patients with soft tissue sarcoma?
Research has shown that neoadjuvant radiotherapy, which involves giving radiation treatment before surgery, is generally safe for people with soft tissue sarcoma. In several studies, patients managed the treatment well. Some experienced mild wound issues, but these were usually easy to handle. One study found that a shorter 5-day treatment was just as safe and effective as the longer 5-week version.
While side effects like skin irritation or tiredness can occur, they usually don't last long. More serious problems, such as severe wound issues, are less common. Overall, the treatment is considered safe and well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the use of MRI at specific timepoints during neoadjuvant radiotherapy for soft tissue sarcoma. Unlike current standard practices, which typically involve MRI imaging only after the completion of radiotherapy, this trial includes additional MRIs at the end of weeks 1, 3, and 5 of treatment. These extra imaging sessions aim to provide a clearer picture of how tumors are responding to treatment in real-time. By tracking these changes during therapy, researchers hope to gather valuable insights that could lead to more personalized and effective treatment strategies in the future.
What evidence suggests that MRI studies at non-SOC timepoints are effective for monitoring soft tissue sarcoma?
Research has shown that giving radiotherapy before surgery for soft tissue sarcoma can be effective. One study found that most patients who received this treatment had no cancer cells at the edges of the removed tissue, which is a positive sign. Another study discovered that a 5-day radiotherapy plan was linked to better long-term results. While not everyone experiences a complete response, those who do often have better outcomes. Overall, neoadjuvant radiotherapy is believed to improve surgery success and long-term health for patients with soft tissue sarcoma.
In this trial, participants will undergo standard-of-care radiotherapy and additional MRI studies at the end of weeks 1, 3, and 5 of their treatment. These MRIs will help assess tumor changes during treatment.56789Are You a Good Fit for This Trial?
This trial is for adults (18+) with confirmed soft tissue sarcoma who are planning to get pre-surgery radiation therapy. Participants must be able to undergo three extra MRI scans during their treatment and have a good general health status. People with Ewing's sarcoma, rhabdomyosarcoma, or those unable to have MRIs can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiotherapy
Participants receive standard of care radiotherapy with additional MRI studies at the end of weeks 1, 3, and 5
Surgical Resection
Participants undergo surgical resection and a single research-specific tissue collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Neoadjuvant Radiotherapy
Trial Overview
The study is testing the use of additional MRI scans at specific times during standard radiation therapy for soft tissue sarcoma. All participants receive the same care; there is no comparison group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will undergo RT therapy per SOC and will receive 3 additional MRI studies at the end of RT weeks 1, 3, and 5. Participants will complete their SOC RT and SOC post-radiation MRI imaging. They will then undergo SOC surgical resection at which time a single research specific tissue collection from discarded tissue not required for clinical pathology will be obtained. Patient participation will be completed after the completion of the surgical resection with no additional follow-up or data collection on survival or disease status as the focus of this feasibility study is on tumor changes during treatment. No other differences from a typical treatment course are expected and no additional anti-cancer therapies will be added as a result of the imaging study results.
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Who Is Running the Clinical Trial?
Andrew Frankart
Lead Sponsor
Citations
Long-Term Follow-Up of Patients Receiving Neoadjuvant ...
Seventy-four patients (54.4%) received neoadjuvant therapy (NT), 62 patients (45.6%) received primary surgery (PS). When receiving NT, patients with high-risk ...
Effect of Favorable Pathologic Response After ...
The median neoadjuvant RT dose was 50 Gy (range, 40-60 Gy), and the majority of patients had negative surgical margins (79%). Only 35 patients (19%) achieved a ...
Neoadjuvant sequential chemoradiotherapy versus ... - PMC
Our study results did not show a statistically significant treatment effect regarding survival and patterns of failure. Keywords: soft tissue sarcoma, ...
Neoadjuvant Radiotherapy in Soft Tissue Sarcomas
In a large cohort where 82% of patients received concurrent anthracycline-based chemotherapy and 34% were treated with Intensity-Modulated ...
Should Neoadjuvant Treatment Be Adopted More Widely ...
The use of neoadjuvant or adjuvant chemotherapy in patients with localized high-risk soft tissue sarcoma (STS) is an ongoing debate.
Neoadjuvant Radiotherapy-Related Wound Morbidity in Soft ...
In general, neoadjuvant RT is associated with more acute wound complications [51,58] while adjuvant RT is associated with higher rates of late toxicities and ...
A Phase II Trial of 5-Day Neoadjuvant Radiation Therapy ...
Secondary endpoints included rates of major wound complications, local control, freedom from distant metastasis (FFDM), and overall survival (OS) ...
A Phase II Trial of 5-Day Neoadjuvant Radiation Therapy ...
2-year and 5-year FFDM rates were 80.1% (95% CI = 72.1-88.1%) and 69.6% (95% CI = 58.2-81.0%), respectively. 2-year and 5-year OS rates were ...
Shorter neoadjuvant radiotherapy regimen effective, safe in ...
A 5-day regimen of neoadjuvant radiotherapy appeared as effective and safe as the conventional 5-week regimen for patients with soft tissue ...
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