Short-course Radiation Therapy for Sarcoma

Overseen By Jackie Hernandez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Active malignancy, Prior irradiation, Pre-op chemotherapy

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

51 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that pre-operative chemotherapy is not allowed, so if you are on chemotherapy, you may need to stop it before joining the trial.

What data supports the effectiveness of the treatment Hypofractionated Radiation Therapy for sarcoma?

Research suggests that hypofractionated radiation therapy (HFRT), which involves giving higher doses of radiation over fewer sessions, may help control sarcoma tumors and improve symptom relief. Studies indicate that HFRT can be as effective as longer radiation courses without increasing side effects, potentially making it a more convenient and cost-effective option for patients. ^{1 2 3 4 5}

Is short-course radiation therapy for sarcoma safe?

Research suggests that short-course radiation therapy, also known as hypofractionated radiation therapy, does not increase the risk of side effects compared to traditional longer courses. It may even improve treatment adherence and cost-effectiveness, although wound complications can occur in about one out of three patients. ^{1 2 3 5 6}

How is hypofractionated radiation therapy different from other treatments for sarcoma?

Hypofractionated radiation therapy (HFRT) is unique because it delivers higher doses of radiation over a shorter period, typically 5-10 treatments, compared to the conventional 5-6 weeks of radiation. This approach may improve patient adherence, reduce costs, and offer more treatment opportunities without increasing side effects or compromising effectiveness. ^{1 2 3 4 5}

Research Team

Anusa Kalbasi, M.D.

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with a certain type of cancer called soft tissue sarcoma in the limbs or trunk. They should be relatively active and healthy (KPS >= 70 or ECOG 0-2), not pregnant if female, and have a tumor that can be surgically removed. Those with recurring cancer are eligible if they haven't had radiation before; however, people actively treating another cancer or who've had pre-op chemo aren't.

Inclusion Criteria

My cancer is a type of sarcoma found in my limbs or trunk.

My sarcoma has come back and I haven't had radiation before.

I can care for myself and perform normal activities.

Exclusion Criteria

I am currently being treated for another cancer.

I have received chemotherapy before surgery.

I have had radiation therapy on the area that needs treatment now.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days

1 week

5 visits (in-person)

Surgery

Patients undergo surgery 2-12 weeks after completion of radiation therapy

2-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 3 months and then every 6 months

Treatment Details

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study tests hypofractionated radiation therapy given over five days before surgery for soft tissue sarcomas. This approach uses higher doses in fewer sessions compared to traditional radiation, aiming to kill more tumor cells while potentially causing fewer side effects.

Participant Groups

Group I: Treatment (hypofractionated radiation therapy) Experimental Treatment 4 Interventions

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Radiological Society of North America

Collaborator

Trials

27

Recruited

1,000+

Sarcoma Alliance for Research through Collaboration

Collaborator

Trials

26

Recruited

2,000+

Tower Cancer Research Foundation

Collaborator

Trials

3

Recruited

100+

Sarcoma Foundation of America

Collaborator

Trials

1

Recruited

50+

Findings from Research

Hypofractionated radiation therapy (HFRT) was effective in providing durable local control and symptom relief for 73 patients with sarcoma, achieving a 1-year local control rate of 73% and a 1-year disease-specific survival rate of 59%.

HFRT was particularly beneficial for patients with oligometastatic (100% survival) and oligoprogressive disease (73% survival), with minimal acute toxicities (49% grade 1-2) and no severe late toxicities, making it a safe option for palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiation Therapy for Unresectable or Metastatic Sarcoma Lesions. Boyce-Fappiano, D., Damron, EP., Farooqi, A., et al.[2022]

Preoperative hypofractionated radiotherapy (HFRT) for soft tissue sarcomas (STS) shows comparable local control rates and similar or lower toxicity compared to traditional normofractionated radiotherapy, based on a systematic review of 13 studies including phase II trials and retrospective analyses.

Shortening the duration of preoperative radiotherapy may improve treatment adherence and cost-effectiveness without increasing adverse effects, making HFRT a promising option for patients with high-grade STS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review. Roohani, S., Ehret, F., Kobus, M., et al.[2022]

Two patients with large high-grade sarcomas successfully underwent hypofractionated radiation therapy (HFRT) combined with chemotherapy before surgery, and neither experienced post-operative wound complications, which is notable given the typical complication rate of one in three for standard treatments.

This case suggests that HFRT may be a promising alternative to traditional radiation regimens, warranting further investigation into its safety and efficacy in preventing wound complications in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy and wound healing after massive sarcoma resection: Case report and review of the literature. Allen, M., Silvino, D., Kamrava, M., et al.[2021]

In a phase II study involving 32 patients with soft tissue sarcomas, a 5-fraction hypofractionated preoperative radiation therapy regimen resulted in no local recurrences and a 3-year overall survival rate of 82.2%.

While the treatment showed excellent local control and survival outcomes, 25% of patients experienced major acute postoperative wound complications, indicating a need for careful monitoring of toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. Bedi, M., Singh, R., Charlson, JA., et al.[2022]

In a study of 16 patients with soft tissue sarcoma, preoperative hypofractionated radiation therapy (30 Gy in 5 fractions) followed by immediate surgical resection resulted in no local failures and a median time of 20 days from biopsy to treatment completion.

Wound healing complications occurred in 31% of patients, with only 19% requiring additional surgery, indicating that this treatment approach has a favorable safety profile in terms of wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection. Parsai, S., Lawrenz, J., Kilpatrick, S., et al.[2022]

In a study of 272 patients with soft tissue sarcomas, hypofractionated preoperative radiotherapy (5 Gy per fraction) demonstrated similar local control rates (81%) compared to conventional radiotherapy, suggesting it is an effective treatment option.

The treatment was associated with manageable early toxicity, with 42% of patients experiencing some form of treatment-related side effects, and only 7% requiring surgical intervention for complications, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. Koseła-Paterczyk, H., Szacht, M., Morysiński, T., et al.[2018]

References

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

Hypofractionated Radiation Therapy for Unresectable or Metastatic Sarcoma Lesions. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy and wound healing after massive sarcoma resection: Case report and review of the literature. [2021]

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

Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. [2022]

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

Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. [2018]