Resectable Soft Tissue Sarcoma, 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 I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Conditions
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.
Interventions
RADIATIONHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDUREResection
Undergo surgical resection
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Wound Complications | Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy | Will be assessed by the number of patients who experience major wound complications within 120 days following surgery. Major wound complication is defined as secondary unplanned operation under general or regional anesthesia for wound repair (e.g., debridement, operative drainage, or secondary wound closure including rotationplasty, free flaps or skin grafts); or wound management without secondary operation including invasive procedures (e.g., aspiration of seroma or readmission for wound care such as intravenous antibiotics or persistent deep packing for 120 days or longer). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Failure Rate | Up to 1 year | Defined as any radiographic or pathologic evidence of recurrent disease inside the clinical target volume (CTV) and/ or to within 3 cm from the edge of the CTV. Local failure rate at 5 years (LFR5) will be evaluated by the number of patients free of local failure/recurrence at 5 years. |
| Percent Probability of Disease-free Survival at 1 Year | up to 1 year | Defined as the time from registration to the earliest date of documentation of local recurrence, regional recurrence, distant recurrence, or death due to any cause |
| Percent Probability of Overall Survival at 1 Year | Up to 1 year | Defined as the time from registration date to death due to any cause |
| Incidence of Late Adverse Events | Between 3 months and 24 months after completion of hypofractionated preoperative radiation therapy | The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for adverse event reporting. The rate of \>= grade 2 late adverse events will be estimated by the number of patients with a \>= grade 2 late adverse events. |
| Pattern of Relapse | Up to 1 years | Pattern of relapse will be evaluated by number of patients with patterns of tumor recurrence such as local recurrence, marginal recurrence, regional recurrence, distant metastasis, and second primary tumor. |
| Incidence of Adverse Events | Up to 1 year | The descriptions and grading scales found in the revised NCI CTCAE version 5.0 will be utilized for adverse event reporting. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. |
| Change in Quality of Life - PROMIS-10 | Baseline up to 24 months post-surgery | Results from the ten-item Patient Reported Outcomes Measurement Information System (PROMIS-10) questionnaire will be used to evaluate physical and mental health separately. The PROMIS-10 consists of ten items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. |
| Change in Quality of Life - TESS | Baseline up to 24 months post-surgery | Results from the Toronto Extremity Salvage Score (TESS) questionnaire will be used to evaluate functional outcomes. The TESS was designed as a measure of the difficulty patients have performing routine daily activities. It consists of 31 items with responses from 1 (impossible to do) to 5 (not at all difficult). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSafia K. Ahmed, M.D.
Mayo Clinic
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Hypofractionated Radiation Therapy, Resection) Patients undergo hypofractionated radiation therapy 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. | 119 |
| Total | 119 |
Baseline characteristics
| Characteristic | Treatment (Hypofractionated Radiation Therapy, Resection) |
|---|---|
| Age, Continuous | 63.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 106 Participants |
| Region of Enrollment United States | 119 participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 117 |
| other Total, other adverse events | 117 / 117 |
| serious Total, serious adverse events | 49 / 117 |
Outcome results
Primary
Major Wound Complications
Will be assessed by the number of patients who experience major wound complications within 120 days following surgery. Major wound complication is defined as secondary unplanned operation under general or regional anesthesia for wound repair (e.g., debridement, operative drainage, or secondary wound closure including rotationplasty, free flaps or skin grafts); or wound management without secondary operation including invasive procedures (e.g., aspiration of seroma or readmission for wound care such as intravenous antibiotics or persistent deep packing for 120 days or longer).
Time frame: Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy
Population: Two patients treated with radiation therapy came off study before surgery because of death.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Hypofractionated Radiation Therapy, Resection) | Major Wound Complications | No | 90 Participants |
| Treatment (Hypofractionated Radiation Therapy, Resection) | Major Wound Complications | Yes | 27 Participants |
Secondary
Change in Quality of Life - PROMIS-10
Results from the ten-item Patient Reported Outcomes Measurement Information System (PROMIS-10) questionnaire will be used to evaluate physical and mental health separately. The PROMIS-10 consists of ten items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life.
Time frame: Baseline up to 24 months post-surgery
Secondary
Change in Quality of Life - TESS
Results from the Toronto Extremity Salvage Score (TESS) questionnaire will be used to evaluate functional outcomes. The TESS was designed as a measure of the difficulty patients have performing routine daily activities. It consists of 31 items with responses from 1 (impossible to do) to 5 (not at all difficult).
Time frame: Baseline up to 24 months post-surgery
Secondary
Disease-free Survival
Defined as the time from registration to the earliest date of documentation of local recurrence, regional recurrence, distant recurrence, or death due to any cause
Time frame: up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Hypofractionated Radiation Therapy, Resection) | Disease-free Survival | 86 Percent Probability |
Secondary
Incidence of Adverse Events
The descriptions and grading scales found in the revised NCI CTCAE version 5.0 will be utilized for adverse event reporting. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
Time frame: Up to 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Hypofractionated Radiation Therapy, Resection) | Incidence of Adverse Events | Grade 3 | 16 Participants |
| Treatment (Hypofractionated Radiation Therapy, Resection) | Incidence of Adverse Events | Grade 4 | 0 Participants |
| Treatment (Hypofractionated Radiation Therapy, Resection) | Incidence of Adverse Events | Grade 5 | 1 Participants |
Secondary
Incidence of Late Adverse Events
The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for adverse event reporting. The rate of \>= grade 2 late adverse events will be estimated by the number of patients with a \>= grade 2 late adverse events.
Time frame: Between 3 months and 24 months after completion of hypofractionated preoperative radiation therapy
Secondary
Local Failure Rate
Defined as any radiographic or pathologic evidence of recurrent disease inside the clinical target volume (CTV) and/ or to within 3 cm from the edge of the CTV. Local failure rate at 5 years (LFR5) will be evaluated by the number of patients free of local failure/recurrence at 5 years.
Time frame: Up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Hypofractionated Radiation Therapy, Resection) | Local Failure Rate | 2 Participants |
Secondary
Overall Survival
Defined as the time from registration date to death due to any cause
Time frame: Up to 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Hypofractionated Radiation Therapy, Resection) | Overall Survival | 97.0 Percent Probability |
Secondary
Pattern of Relapse
Pattern of relapse will be evaluated by number of patients with patterns of tumor recurrence such as local recurrence, marginal recurrence, regional recurrence, distant metastasis, and second primary tumor.
Time frame: Up to 1 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Hypofractionated Radiation Therapy, Resection) | Pattern of Relapse | 2 Participants |