Clinical trial NCT04562480: Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk
Official title: A Phase II Study of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial investigates the effects of hypofractionated radiation therapy before surgery on wound complications associated with surgery in treating patients with soft tissue sarcoma of the extremity (arms, hands, legs or feet) and superficial trunk that has not spread to other parts of the body (localized) and can be removed by surgery (resectable). Hypofractionated is a shorter radiation therapy treatment length (fewer radiation treatment days) and administers the total radiation dose as larger daily doses, compared to conventionally fractionated therapy.

Detailed description: PRIMARY OBJECTIVE:

I. To report the major acute wound complication rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

SECONDARY OBJECTIVES:

I. To report the 5-year local failure rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

II. To report the 5-year disease-free survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

III. To report the 5-year overall survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

IV. To report long-term toxicity rates associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

V. To describe patterns of relapse associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

VI. To describe patient reported outcomes/quality-of-life outcomes with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions.

OUTLINE:

Patients undergo hypofractionated radiation therapy once daily (QD) (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.

After completion of study treatment, patients are followed up at 4-8 weeks, every 3-4 months for years 1-2, and every 6 months for years 3-5.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, histological confirmation of soft tissue sarcoma of the extremities (including limb girdle) or superficial trunk that present as either -

  * Deemed a candidate for complete macroscopic resection of the primary sarcoma OR
  * Having had non-oncologic excisional procedure with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of preoperative radiation therapy
* No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 3
* Life expectancy greater than 6 months
* Patients capable of childbearing must use adequate contraception
* Ability to complete questionnaire(s) by themselves or with assistance
* Ability to provide written informed consent
* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

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
* Rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, and benign histologies
* Any of the following:

  * Pregnant women
  * Nursing women
  * Men or women of childbearing potential who are unwilling to employ adequate contraception

Primary outcomes:
measure: Major wound complications
timeFrame: Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy
Secondary outcomes:
measure: Local failure rate
timeFrame: At 5 years
measure: Disease-free survival
timeFrame: From registration date to the earliest date of documentation of either, local recurrence, regional recurrence, distant recurrence, or death due to any cause, assessed up to 5 years
measure: Overall survival
timeFrame: From registration date to death due to any cause, assessed up to 5 years
measure: Incidence of late adverse events
timeFrame: Between 3 months and 24 months after completion of hypofractionated preoperative radiation therapy
measure: Pattern of relapse
timeFrame: Up to 5 years
measure: Incidence of adverse events
timeFrame: Up to 5 years
measure: Change in quality of life - PROMIS-10
timeFrame: Baseline up to 24 months post-surgery
measure: Change in quality of life - TESS
timeFrame: Baseline up to 24 months post-surgery
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Safia K. Ahmed, M.D.
role: PRINCIPAL_INVESTIGATOR
References: