Radiation Therapy for Sarcoma

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Age over 25, Prior irradiation, 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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for children and young adults with tumors in the bones and soft tissues. The goal is to focus radiation more precisely on the tumor using advanced imaging techniques, such as CT and MRI scans, to better target the cancer while protecting healthy tissue. The trial seeks participants with a musculoskeletal tumor that has not previously received radiation and requires radiation as part of their treatment plan. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that image-guided radiotherapy is safe for pediatric tumors?

Research has shown that image-guided radiotherapy (IGRT) is generally well-tolerated for treating sarcomas. Studies have found that advanced imaging techniques like CT, MRI, and PET help focus radiation directly on the tumor, reducing risk to nearby healthy tissues. This precise targeting can lessen the side effects often linked with radiation therapy.

One study found that while some complications may occur, they are usually mild and acceptable. Most patients experience only mild side effects. Thus, IGRT is considered a safe option for treating tumors, with fewer severe reactions compared to traditional methods. Overall, IGRT shows promise for effectively managing tumors while keeping side effects low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for sarcoma, which typically involves conventional radiotherapy, image-guided radiotherapy (IGRT) offers a cutting-edge approach by using advanced imaging techniques to precisely target tumors. This method allows for more accurate radiation delivery, potentially minimizing damage to surrounding healthy tissues. Researchers are excited about IGRT because it could enhance treatment effectiveness and reduce side effects, offering a promising improvement over traditional methods.

What evidence suggests that image-guided radiotherapy is effective for sarcoma?

Studies have shown that image-guided radiotherapy (IGRT), the treatment being evaluated in this trial, effectively treats sarcomas, which are tumors that form in bones and soft tissues. One study found that in difficult cases, this treatment kept the cancer under control in 86% of patients for at least five years. Research also shows that IGRT can reduce long-term side effects, making it a safer choice for many patients. Overall, IGRT provides good control of the tumor while protecting nearby healthy tissue. ^{2 6 7 8 9}

Who Is on the Research Team?

Matthew J Krasin, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for individuals up to 25 years old with musculoskeletal tumors such as sarcoma, who haven't had prior radiation at the tumor site (except for emergency treatment). It includes those with or without metastatic disease and allows patients undergoing various treatments like surgery or chemotherapy. Pregnant women can't participate, and those with recurrent tumors are eligible if the area hasn't been irradiated before.

Inclusion Criteria

Patients enrolled prior to amendment 4.0, who are still in active participation will be reconsented to the current version of the protocol (5.0).

Negative serum or urine beta-HCG for females of child bearing age.

I am 25 years old or younger and enrolling for the first time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-radiotherapy Evaluation and Treatment Planning

Eligible patients undergo a pre-radiotherapy evaluation and treatment planning

1-2 weeks

Image-guided Radiotherapy Delivery

Participants receive image-guided radiotherapy to treat musculoskeletal tumors

6-8 weeks

Intra-and Post-irradiation Evaluations

Participants undergo evaluations during and after irradiation to assess treatment effects

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Image-guided radiotherapy

Trial Overview The study tests image-guided radiotherapy (IGRT) in treating pediatric bone and soft tissue tumors. IGRT uses advanced imaging techniques like CT, MRI, and PET scans to target radiation precisely at the tumor while sparing healthy tissues around it.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Lance Armstrong Foundation

Collaborator

Trials

10

Recruited

1,100+

Published Research Related to This Trial

In a study of 70 patients with extremity soft tissue sarcoma, a 20% increase in tumor size during preoperative radiotherapy did not negatively impact disease-specific or metastasis-free survival outcomes compared to patients whose tumors remained stable or decreased in size.

The findings suggest that tumor size increase during radiotherapy may not be a poor prognostic indicator, allowing for more conservative surgical approaches without compromising patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor size increase following preoperative radiation of soft tissue sarcomas does not affect prognosis. Delisca, GO., Alamanda, VK., Archer, KR., et al.[2022]

Proton beam therapy offers a significant dosimetric advantage over traditional x-ray radiation therapy by reducing radiation exposure to healthy tissues, which could enhance treatment outcomes for sarcomas.

This therapy may improve the therapeutic ratio by either increasing the dose to the tumor for better local control or decreasing complications in surrounding normal tissues, making it a promising option for sarcoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton therapy for sarcomas. Keole, S., Ashman, JB., Daniels, TB.[2014]

In a phase II study involving 52 patients with high-risk primary soft tissue sarcoma, a 5-day neoadjuvant radiotherapy regimen resulted in a low rate of grade ≥2 late radiation toxicity (16%) and a 32% incidence of major wound complications.

The study identified a potential germline biomarker that could predict major wound complications, which may help improve the safety and effectiveness of radiotherapy in future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II Trial of 5-Day Neoadjuvant Radiotherapy for Patients with High-Risk Primary Soft Tissue Sarcoma. Kalbasi, A., Kamrava, M., Chu, FI., et al.[2021]

In a study of 59 patients with extremity soft tissue sarcomas, intensity-modulated radiotherapy (IMRT) resulted in late toxicities in 75% of patients, with the majority being mild to moderate (G1-2), including functional limitations and chronic pain.

A larger volume of healthy soft tissue surrounding the treatment area (greater than 3500 cm³) was associated with reduced late toxicities, suggesting that careful planning of radiotherapy can help minimize side effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of intensity-modulated radiotherapy toxicity in extremity soft tissue sarcomas patients: A role for irradiated healthy soft tissue volume? Bourdais, R., Achkar, S., Honoré, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7693687/

Radiation Therapy in Adult Soft Tissue Sarcoma—Current ... Data from a recent European analysis demonstrated a 5-year local control rate of 86% combining EBRT with an IORT boost in an unfavourable ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2468294222001460

Real-world clinical outcomes with daily image-guided ... Our results showed that IMRT with daily imaging offered excellent local control with acceptable long-term toxicity, as well as being feasible and practical to ...

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89829-2/abstract

Meta-analysis of 5-day preoperative radiotherapy for soft ... 5-day RT preoperative courses in sarcomas have acceptable complication rates, although some studies show a higher wound complication rate.

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02238-z

Outcome of patients with soft tissue sarcomas of the ... Radiotherapy is generally effective in improving locoregional control in STS which led to prolonged survival in large registry analyses [8, 21].

5. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2014.58.5828

Results of Radiation Therapy Oncology Group RTOG-0630 ... Significant Reduction of Late Toxicities in Patients With Extremity Sarcoma Treated With Image-Guided Radiation Therapy to a Reduced Target ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4647667/

Study of Preoperative Radiotherapy for Sarcomas of the ... The data of the present PREMISS study will enhance the current literature and support the hypothesis that neoadjuvant RT with IMRT/IGRT offers an excellent risk ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424001258

Preoperative Ultrahypofractionated Radiation Therapy for ... Increasing reports on mild hypofractionated or uhRT data from phase 1/2 studies and patient cohorts consistently confirm comparable outcomes with preoperative ...

8. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-019-1207-2

Neoadjuvant image-guided helical intensity modulated ... This work aims to evaluate toxicity and outcome after neoadjuvant image-guided radiotherapy (IGRT) as helical intensity modulated radiotherapy ( ...

9. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)01812-9/abstract

Safety and efficacy of pembrolizumab, radiation therapy ... Grade 3 or higher adverse events occurred more frequently in the experimental group (56%) than the control group (31%). Interpretation. Addition ...