Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk

Phase 2

Active, not recruiting

• Conditions: Resectable Soft Tissue Sarcoma; Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC V8; Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC V8; Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC V8; Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC V8; Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC V8; Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC V8; Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC V8
• Interventions: Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03819985
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by 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. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine, in patients with localized, resectable soft tissue sarcoma, whether there is a non-inferior major wound complication rate for patients receiving 42.75 Gy in 15 fractions over 3 weeks compared to historical controls who received 50 Gy in conventional fractionation over 5-6 weeks.

SECONDARY OBJECTIVES:

I. To determine whether local control rates among patients treated with 42.75 Gy in 15 fractions is similar to that observed in previous studies for patients treated with 50 Gy in conventional fractionation over 5-6 weeks.

II. To determine whether patterns of local relapse, relapse free survival, overall survival, or metastatic disease free survival for patients treated with 42.75 Gy in 15 fractions are similar to previously reported studies.

III. To determine where there is a difference in pathologic response in tumor specimens treated with 42.75 Gy in 15 fractions compared to previously reported rates of hyalinization, fibrosis, or necrosis.

IV. To explore quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G), financial toxicity as measured by the Comprehensive Score for financial Toxicity (COST) Instrument, and patient reported outcomes, as measured by the Toronto Extremity Salvage Score (TESS), among individuals undergoing a shorter, hypofractionated course of pre-operative radiation therapy for soft tissue sarcoma of the extremity or superficial trunk.

V. To gather subjective data on patient treatment preferences and experiences among individuals undergoing a shorter, hypofractionated course of pre-operative radiation therapy for soft tissue sarcoma of the extremity or superficial trunk.

OUTLINE:

Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-4 months for 2 years, every 6 months for 3 years, and then every year for up to 10 years.

Study Timeline

• Study Start: 2018-12-17
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Tumor located in the soft tissues of the extremities or superficial trunk
• Deemed a candidate for complete macroscopic resection of the primary sarcoma
• Histologically confirmed sarcoma arising in soft tissue
• Patient may have had excisional biopsy of all gross disease at an outside facility with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon in the participating institution recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of neoadjuvant irradiation (a sandwich approach of marginal excision-->radiation therapy(RT)--> wide excision, as per our standard practice)
• No evidence of nodal or distant metastases as determined by clinical examination or any form of imaging
• Has provided written informed consent for participation in this trial
• Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
• Life expectancy greater than 6 months
• Patients capable of childbearing are using adequate contraception
• Available for follow-up

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Exclusion Criteria

• Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma. In other words, treatment on this trial would require re-irradiation of tissues
• Patients with nodal or distant metastases
• Women who are pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (hypofractionated RT)	Hypofractionated Radiation Therapy	Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment (hypofractionated RT)	Questionnaire Administration	Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment (hypofractionated RT)	Quality-of-Life Assessment	Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Time to a major wound complication (MWC)	Up to 120 days after surgery	A Bayesian approach for the analysis of a stopping rule of higher acute wound complications for the new dose (E) will be employed.

Secondary Outcome Measures

Name	Time	Method
Disease free survival (DFS) time	Up to 10 years after radiation therapy	The data from long-term follow-up will be analyzed for disease-free survival. Kaplan-Meier curves will be generated of survival estimates. Will compare these to historical controls.
Incidence of late onset toxicity	Up to 120 days after radiation therapy	Late radiation toxicity will be documented and rates tabulated.
Local recurrence free survival	Up to 10 years after radiation therapy	The data from long-term follow-up will be analyzed for the local recurrence free survival. Kaplan-Meier curves will be generated of survival estimates. We will compare these to historical controls.
Pattern of local relapse (in radiation field, margin of field, out of radiation field)	Up to 10 years after radiation therapy
Time to relapse	Up to 10 years after radiation therapy
Disease specific survival time	Up to 10 years after radiation therapy	Kaplan-Meier curves will be generated of survival estimates.
Incidence of acute toxicity other than MWC	Up to 120 days after radiation therapy	Acute toxicity will be documented and rates tabulated.
Functional outcomes	Up to 10 years after radiation therapy	Limb function and overall patient quality of life/functional status will be documented according to the Musculoskeletal Tumor Society (MSTS) and Toronto Extremity Salvage Score (TESS) and Euroqol-5D (EQ5D), which will be summarized and analyzed as a continuous variable. Differences between mean scores will be tested using the Mann-Whitney test. Mean and median and their 95% confidence interval (CI) will be presented.
Quality of life	Up to 10 years after radiation therapy	Limb function and overall patient quality of life/functional status will be documented according to the MSTS and TESS and Euroqol-5D (EQ5D), which will be summarized and analyzed as a continuous variable. Differences between mean scores will be tested using the Mann-Whitney test. Mean and median and their 95% CI will be presented.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States