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

202 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers at St. Jude Children's Research Hospital are looking for more effective ways to deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the study is to improve local control of musculoskeletal tumors with image-guided radiation therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to precisely define tumor location and to carefully plan radiation treatment. This approach allows doctors to deliver highly conformal radiation therapy to the tumor while protecting nearby healthy normal tissues.

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 data supports the effectiveness of the treatment Image-guided radiotherapy for sarcoma?

Research shows that radiation therapy, when combined with surgery, provides excellent local control of sarcomas, meaning it helps keep the cancer from coming back in the treated area. Additionally, using radiotherapy before surgery can improve local control and allow for less extensive surgery. ^{1 2 3 4 5}

Is radiation therapy generally safe for humans?

Radiation therapy can sometimes lead to the development of new sarcomas (a type of cancer) in the treated area, which is a rare but serious complication. Studies have shown that while this risk exists, it is not common, and the therapy is generally considered safe for many patients. ^{3 6 7 8 9}

How is image-guided radiotherapy different from other treatments for sarcoma?

Image-guided radiotherapy (IG-RT) is unique because it uses imaging technology to precisely target the tumor, allowing for more accurate delivery of radiation to the sarcoma while minimizing damage to surrounding healthy tissue. This precision can improve treatment outcomes and reduce side effects compared to traditional radiotherapy methods. ^{2 10 11 12 13}

Research Team

Matthew J Krasin, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Sarcoma therapy: functional outcome and relationship to treatment parameters. [2019]

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

Outpatient chemotherapy plus radiotherapy in sarcomas: improving cancer control with radiosensitizing agents. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Post-radiation sarcomas: a review of the clinical and imaging features in 63 cases. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

[Radiotherapy of bone tumors. Analysis of a historic series and review of the literature]. [2011]

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

Tumor size increase following preoperative radiation of soft tissue sarcomas does not affect prognosis. [2022]

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

A Phase II Trial of 5-Day Neoadjuvant Radiotherapy for Patients with High-Risk Primary Soft Tissue Sarcoma. [2021]

7. France pubmed.ncbi.nlm.nih.gov

[Sarcoma developed in irradiated area: Preliminary results of the SARI trial]. [2017]

8. Ireland 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? [2022]

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

Radiation-induced sarcomas after radiotherapy for breast carcinoma: a large-scale single-institution review. [2022]

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

Association between biologically effective dose and local control after stereotactic body radiotherapy for metastatic sarcoma. [2023]

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

Radiotherapy for soft tissue sarcoma: 50 years of change and improvement. [2018]

12. France pubmed.ncbi.nlm.nih.gov

[Radiotherapy as conservative therapy for sarcomas within the irradiated field]. [2014]

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

Proton therapy for sarcomas. [2014]