IMRT for Soft Tissue Sarcoma

Not currently recruiting at 7 trial locations

Overseen By Anthony Griffin, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mount Sinai Hospital, Canada

Disqualifiers: Prior malignancy, Prior radiotherapy, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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 explores how radiation therapy, administered either before or after surgery, affects wound healing in individuals with soft tissue sarcoma—a cancer affecting muscles, fat, nerves, and blood vessels—in the arms, legs, or trunk. One group will receive preoperative intensity modulated radiation therapy (before surgery), while the other will receive postoperative intensity modulated radiation therapy (after surgery). The trial aims to determine if the timing of radiation treatment impacts short-term healing post-surgery. Individuals diagnosed with soft tissue sarcoma in these areas who are ready for surgery and radiation therapy may qualify for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are planning to undergo chemotherapy, you would not be eligible for this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that preoperative intensity modulated radiation therapy (IMRT) is generally well-tolerated. This type of radiation therapy targets tumors more precisely, and research indicates it has similar rates of wound complications and late side effects compared to other methods. Previous studies suggest that patients experience manageable side effects.

For postoperative IMRT, research also supports its safety. It provides good tumor control and causes fewer long-term side effects than older radiation techniques. Patients have reported fewer serious complications, making it a safer option for treating soft tissue sarcomas in the arms, legs, and trunk.

Both preoperative and postoperative IMRT have been tested in people, and the results are promising in terms of safety. While any treatment can have side effects, these studies suggest that both approaches are generally safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about intensity modulated radiation therapy (IMRT) for soft tissue sarcoma because it offers a more precise delivery of radiation compared to traditional methods. IMRT allows doctors to target tumors with high doses of radiation while minimizing damage to surrounding healthy tissues. This precision could lead to fewer side effects and potentially better outcomes for patients. Additionally, the trial is exploring both preoperative and postoperative applications of IMRT, which could help determine the most effective timing for treatment, offering new insights into how to best manage soft tissue sarcoma.

What evidence suggests that this trial's treatments could be effective for soft tissue sarcoma?

This trial will compare the effectiveness of preoperative and postoperative intensity modulated radiation therapy (IMRT) for treating soft tissue sarcoma. Research has shown that both approaches are effective. Participants in Arm A will receive preoperative IMRT, which studies indicate can reduce the radiation dose to the skin and nearby tissues, resulting in fewer side effects. Patients using this approach have experienced good control of the cancer in the treated area with satisfactory long-term outcomes. Participants in Arm B will receive postoperative IMRT, where evidence shows excellent control of the cancer and low rates of late side effects, especially for tumors in the arms, legs, and body. Both methods have improved control of the cancer in the treated area, making them promising options for managing soft tissue sarcomas. ^{1 6 7 8 9}

Who Is on the Research Team?

Peter Chung, MD

Principal Investigator

Princess Margaret Cancer Centre

Peter Ferguson, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for adults over 18 with soft tissue sarcoma in the limbs or torso, who are fit enough for surgery and radiotherapy. They must have a tumor that's either new or has come back after treatment. Patients should be able to consent to treatment and follow-up, and have an ECOG score between 0-3.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.

I am available for all treatments and follow-up appointments.

My cancer is either new or has locally returned, and experts agree IMRT is suitable for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Radiation Therapy

Participants receive preoperative intensity modulated radiation therapy followed by surgery

5 weeks

Once per week

Postoperative Radiation Therapy

Participants undergo surgery followed by postoperative intensity modulated radiation therapy

4 weeks

Once per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Postoperative intensity modulated radiation therapy
• Preoperative intensity modulated radiation therapy

Trial Overview The study compares two approaches using IMRT: one where patients get radiation before surgery (preoperative) and another where they get it after (postoperative). The goal is to see which method leads to fewer wound healing complications shortly after surgery.

How Is the Trial Designed?

Group I: Preoperative Radiation Therapy (Arm A) Experimental Treatment 1 Intervention

Preoperative intensity modulated radiation therapy followed by surgery

Group II: Postoperative Radiation Therapy (Arm B) Experimental Treatment 1 Intervention

Surgery followed by postoperative intensity modulated radiation therapy

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Published Research Related to This Trial

In a study of 16 patients with lower extremity soft tissue sarcoma, both sliding-window IMRT (SW-IMRT) and volumetric arc therapy (VMAT) provided excellent coverage of the target areas after surgery, but VMAT was more effective in reducing radiation exposure to critical organs-at-risk.

SW-IMRT was better at sparing the normal tissue corridor, which is important for minimizing the risk of lymphedema, highlighting the strengths of both techniques in postoperative radiotherapy planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric comparison of volumetric-arc therapy versus sliding window intensity-modulated radiotherapy in postoperative treatment for primary soft tissue sarcoma of the thigh. Ortiz González, I., Morera Cano, D., Roncero Sánchez, R., et al.[2020]

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]

In a study of 274 patients with nonmetastatic soft tissue sarcoma, those treated with postoperative intensity-modulated radiation therapy (IMRT) showed significantly better survival outcomes compared to those receiving two-dimensional radiotherapy (2D-RT), including higher rates of local recurrence-free survival (91.1% vs 80.8%) and overall survival (90.2% vs 81.0%).

Patients receiving IMRT also experienced fewer late toxicities, such as lower rates of joint stiffness (3.9% vs 12.3%) and no cases of severe fractures, suggesting that IMRT is not only more effective but also safer than traditional 2D-RT for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcome and toxicity of postoperative intensity-modulated radiation therapy with two-dimensional radiotherapy in patients with soft tissue sarcoma of extremities and trunk. Wang, J., Song, Y., Liu, X., et al.[2021]

Postoperative intensity-modulated radiation therapy (IMRT) for patients with soft tissue sarcomas (STSs) in the extremities and trunk wall resulted in an impressive 5-year local control rate of 88.1%, especially for patients with negative surgical margins (90% local control) compared to those with positive margins (64.8%).

The treatment demonstrated low toxicity, with only 17.6% of patients experiencing edema and 9.8% experiencing joint stiffness, indicating that IMRT is a safe and effective option for managing STSs post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative intensity-modulated radiation therapy provides favorable local control and low toxicities in patients with soft tissue sarcomas in the extremities and trunk wall. Wang, J., Wang, S., Song, Y., et al.[2020]

In a study of 10 patients with lower extremity soft tissue sarcoma treated with adjuvant intensity-modulated radiation therapy (IMRT) after limb-sparing surgery, 40% of patients were disease-free, indicating potential effectiveness in maintaining local control of the disease.

The treatment was associated with manageable side effects, with only mild to moderate toxicity reported, such as edema and joint stiffness, and no severe complications like infections or nerve damage, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of limb salvage surgery with postoperative intensity-modulated radiation therapy for soft-tissue sarcoma and metastasis. Kawanami, K., Matsuo, T., Yuki, S., et al.[2022]

In a study of 31 adult patients with primary soft tissue sarcoma of the extremity, intensity modulated radiation therapy (IMRT) as an adjuvant treatment showed a high local control rate of 95% over a median follow-up of 23 months.

While some patients experienced side effects such as Grade 1 radiation dermatitis (71%) and Grade 1 neuropathy (28%), the overall morbidity profile was considered favorable, suggesting that IMRT is a promising option for high-risk sarcoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity modulated radiation therapy for primary soft tissue sarcoma of the extremity: preliminary results. Alektiar, KM., Hong, L., Brennan, MF., et al.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4608545/

Postoperative intensity-modulated radiation therapy ... Postoperative IMRT provides excellent LC and low late morbidity rates in patients with STSs in the extremities and trunk wall. These findings clearly indicate ...

2. redjournal.org redjournal.org/article/S0360-3016(24)00687-4/fulltext

The IMRiS Trial: A Phase 2 Study of Intensity Modulated ... In conclusion, we have demonstrated that IMRT for limb sarcomas results in a low rate of grade ≥2 soft tissue fibrosis (subcutaneous tissue) at ...

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

Real-world clinical outcomes with daily image-guided ... We report the clinical outcomes of patients with soft tissue sarcomas (STS) arising in extremities treated with image-guided intensity modulated radiotherapy ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9985237/

Outcome of patients with soft tissue sarcomas ... Conformal, intensity-modulated radiotherapy is an effective treatment modality in the preoperative or postoperative management of STS.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2008.16.6249

Impact of Intensity-Modulated Radiation Therapy on Local ... The margins were positive/within 1 mm in 21. Tumor size was more than 10 cm in 68% of patients and grade was high in 83%. Preoperative IMRT was given to 7 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30740916/

Comparison of outcome and toxicity of postoperative ... When compared with conventional techniques, postoperative IMRT seems to provide better LRFS, DMFS, DFS, and OS and less late toxicities in patients with STS ...

7. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-022-02166-4

Postoperative complications and oncologic outcomes after ... Preoperative versus postoperative radiation therapy for soft tissue sarcoma: a retrospective comparative evaluation of disease outcome. Int ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2452109423002191

Novel Postoperative Hypofractionated Accelerated ... This study evaluates the acute toxicity of a hypofractionated accelerated RT dose-painting (HARD) approach for postoperative treatment of STS.

9. practicalradonc.org practicalradonc.org/article/S1879-8500(21)00118-1/fulltext

Radiation Therapy for Treatment of Soft Tissue Sarcoma in ... This guideline provides evidence-based recommendations addressing the indications for radiation therapy (RT), sequencing of local therapies, ...