IMRT for Soft Tissue Sarcoma

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

210 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to determine if preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in similar short-term wound healing complications as surgery followed by postoperative IGRT in patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive preoperative radiotherapy, half will receive postoperative radiotherapy.

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.

What data supports the effectiveness of the treatment IMRT for Soft Tissue Sarcoma?

Research shows that intensity-modulated radiation therapy (IMRT) improves local control of soft tissue sarcoma after surgery compared to older methods, and combining pre- and postoperative radiation can maximize benefits by reducing tumor size and improving precision. Preoperative IMRT can also reduce complications by targeting the tumor more accurately, while postoperative IMRT helps manage long-term outcomes. ^{1 2 3 4 5}

Is intensity-modulated radiation therapy (IMRT) safe for humans?

Research shows that intensity-modulated radiation therapy (IMRT) for soft tissue sarcoma generally has low toxicities (side effects) and is considered safe, with studies indicating favorable outcomes in terms of safety when used both before and after surgery. ^{1 2 4 6 7}

How is IMRT treatment different for soft tissue sarcoma?

IMRT (intensity-modulated radiation therapy) is unique for treating soft tissue sarcoma because it allows precise targeting of the tumor, reducing damage to surrounding healthy tissue and minimizing side effects compared to traditional radiation methods. This approach improves local control of the cancer and reduces the risk of complications after surgery. ^{1 2 7 8 9}

Research Team

Peter Chung, MD

Principal Investigator

Princess Margaret Cancer Centre

Peter Ferguson, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States 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. [2021]

2. Australia 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. [2020]

3. Ireland pubmed.ncbi.nlm.nih.gov

Preoperative stereotactic ablative body radiotherapy with postoperative conventional irradiation of soft tissue sarcomas: Protocol overview with a preliminary safety report. [2022]

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

Phase 2 study of preoperative image-guided intensity-modulated radiation therapy to reduce wound and combined modality morbidities in lower extremity soft tissue sarcoma. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Pre- or postoperative radiotherapy for soft tissue sarcomas. [2020]

6. 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]

7. New Zealand 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. [2020]

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

Intensity modulated radiation therapy for primary soft tissue sarcoma of the extremity: preliminary results. [2007]

9. India pubmed.ncbi.nlm.nih.gov

Clinical outcomes of limb salvage surgery with postoperative intensity-modulated radiation therapy for soft-tissue sarcoma and metastasis. [2022]