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Hypofractionated Radiation Therapy Before Surgery for the Treatment of Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated Radiation Therapy
Quality-of-Life Assessment
Questionnaire Administration
Resection
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resectable Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in ArizonaRecruiting
  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (hypofractionated radiation therapy, resection)

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of patients who experience major wound complications
Will be estimated by the number of patients who experience the major wound complications within 120 days following surgery divided by the total number of evaluable patients. 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). 95% confidence intervals using normal approximation to binomial wound complication proportion will be calculated.

Secondary Outcome Measures

Local failure rate
Will be defined 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 year divided by the total number of evaluable patients. Exact binomial 95% confidence interval for the point estimate will be provided. In the case of censoring prior to 5 years, LFR5 will be estimated using the Kaplan-Meier method.
Disease-free survival
The distribution of disease-free survival will be estimated using method of Kaplan-Meier.
Overall survival
The distribution of overall survival will be estimated using method of Kaplan-Meier.
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 event divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true rate of >= grade 2 late adverse events will be calculated.
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 divided by the total number of evaluable patients. Exact binomial 95% confidence interval for the point estimate will be provided.
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. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Change in quality of life
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 Wilcoxon signed-rank test will be utilized to assess changes in raw PROMIS scores. Mean change, along with standard deviation will be reported.
Change in quality of life
Results from the Toronto Extremity Salvage Score (TESS) questionnaire will be used to evaluate functional outcomes. Mean change from baseline to 24 months post-surgery, along with standard deviation will be reported by version. The Wilcoxon signed-rank test will be utilized to assess changes in TESS scores within questionnaires.

Full Information

First Posted
September 18, 2020
Last Updated
August 9, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04562480
Brief Title
Hypofractionated Radiation Therapy Before Surgery for the Treatment of 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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
November 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (hypofractionated radiation therapy, resection)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiation Therapy
Other Intervention Name(s)
Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Intervention Description
Undergo hypofractionated radiation therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Resection
Other Intervention Name(s)
Surgical Resection
Intervention Description
Undergo surgical resection
Primary Outcome Measure Information:
Title
Proportion of patients who experience major wound complications
Description
Will be estimated by the number of patients who experience the major wound complications within 120 days following surgery divided by the total number of evaluable patients. 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). 95% confidence intervals using normal approximation to binomial wound complication proportion will be calculated.
Time Frame
Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy
Secondary Outcome Measure Information:
Title
Local failure rate
Description
Will be defined 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 year divided by the total number of evaluable patients. Exact binomial 95% confidence interval for the point estimate will be provided. In the case of censoring prior to 5 years, LFR5 will be estimated using the Kaplan-Meier method.
Time Frame
At 5 years
Title
Disease-free survival
Description
The distribution of disease-free survival will be estimated using method of Kaplan-Meier.
Time Frame
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
Title
Overall survival
Description
The distribution of overall survival will be estimated using method of Kaplan-Meier.
Time Frame
From registration date to death due to any cause, assessed up to 5 years
Title
Incidence of late adverse events
Description
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 event divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true rate of >= grade 2 late adverse events will be calculated.
Time Frame
Between 3 months and 24 months after completion of hypofractionated preoperative radiation therapy
Title
Pattern of relapse
Description
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 divided by the total number of evaluable patients. Exact binomial 95% confidence interval for the point estimate will be provided.
Time Frame
Up to 5 years
Title
Incidence of adverse events
Description
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. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Time Frame
Up to 5 years
Title
Change in quality of life
Description
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 Wilcoxon signed-rank test will be utilized to assess changes in raw PROMIS scores. Mean change, along with standard deviation will be reported.
Time Frame
Baseline up to 24 months post-surgery
Title
Change in quality of life
Description
Results from the Toronto Extremity Salvage Score (TESS) questionnaire will be used to evaluate functional outcomes. Mean change from baseline to 24 months post-surgery, along with standard deviation will be reported by version. The Wilcoxon signed-rank test will be utilized to assess changes in TESS scores within questionnaires.
Time Frame
Baseline up to 24 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivy A Petersen, M.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Safia K. Ahmed, M.D.
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Ivy A Petersen, M.D.

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Hypofractionated Radiation Therapy Before Surgery for the Treatment of Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk

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