Trial Outcomes & Findings for Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall (NCT NCT02634710)
NCT ID: NCT02634710
Last Updated: 2025-12-02
Results Overview
This measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
2 Years
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
Hypofractionated Radiation Therapy
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Hypofractionated Radiation Therapy
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Overall Study
Death
|
4
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Baseline Characteristics
Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
Baseline characteristics by cohort
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=121 Participants
|
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Age, Categorical
Between 18 and 65 years
|
17 Participants
n=121 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=121 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 15.4 • n=121 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=121 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=121 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
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Region of Enrollment
United States
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35 participants
n=121 Participants
|
PRIMARY outcome
Timeframe: 2 YearsThis measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
|
|---|---|
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Local Disease Control Assessed by Physical Examination
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThis measure is the number of subjects experiencing a recurrence of the primary lesion as assessed by MRI.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Local Disease Control Assessed by Magnetic Resonance Imaging (MRI)
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, prior to surgery and 24 months after surgeryToxicity will be assessed at specific times the Musculoskeletal Tumor Rating Scale. The MSTS evaluates: pain, function, emotional acceptance, hand positioning, dexterity and lifting ability, using a six-item Likert scale ranging from 0 (worst condition) to 5 (best condition). The individual scores are added for the MSTS Score, range 0 to 30. A higher score indicates better function.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Musculoskeletal Tumor Rating Scale (MSTS) Score
Baseline
|
29 units on a scale
Standard Deviation 1.05
|
|
Musculoskeletal Tumor Rating Scale (MSTS) Score
2 years
|
27.3 units on a scale
Standard Deviation 2.47
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|
Musculoskeletal Tumor Rating Scale (MSTS) Score
Prior to Surgery
|
28.3 units on a scale
Standard Deviation 2.06
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SECONDARY outcome
Timeframe: 2 YearsDisease-free survival will measure the time in months from initiation of radiation therapy until documented recurrence of disease. Patients who are disease-free and alive at the time of analysis will be censored at the time of their last follow-up. Patients will be assessed for disease-free survival at 2 years.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Disease-free Survival
|
32 Participants
|
SECONDARY outcome
Timeframe: 2 YearsOverall survival will measure the time from initiation of radiation therapy until documented death from any cause. Patients who are alive at the time of analysis will be censored at the time of their last follow-up. Patients will be assessed for overall survival at 2 years.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Overall Survival
|
32 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after radiation therapyThis measure will assess the size of enhancement due to hypofractionated radiation.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Radiologic Changes Due to Hypofractionated Radiation.
|
-16.2 cubic centimeters
Standard Deviation 25
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SECONDARY outcome
Timeframe: 2 weeks after surgeryThis measure will capture the fibrosis present in tissue specimens as a percent.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Pathologic Changes Due to Hypofractionated Radiation.
Necrosis
|
17.5 percentage of tumor specimen
Standard Deviation 26.4429
|
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Pathologic Changes Due to Hypofractionated Radiation.
Fibrosis
|
20 percentage of tumor specimen
Standard Deviation 32.5364
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Pathologic Changes Due to Hypofractionated Radiation.
Viable Cells
|
50 percentage of tumor specimen
Standard Deviation 31.9287
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SECONDARY outcome
Timeframe: 2 yearsNumber of participants who experienced treatment-related necrosis and fibrosis ≥90%.
Outcome measures
| Measure |
Hypofractionated Radiation Therapy
n=35 Participants
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Treatment-related Necrosis and Fibrosis
Treatment-related necrosis
|
4 Participants
|
|
Treatment-related Necrosis and Fibrosis
Treatment-related fibrosis
|
4 Participants
|
Adverse Events
Hypofractionated Radiation Therapy
Serious events: 19 serious events
Other events: 20 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Hypofractionated Radiation Therapy
n=35 participants at risk
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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Cardiac disorders
Cardiac arrest
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Endocrine disorders
Hyper parathyroidism
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
General disorders
Pain
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Infections and infestations
Wound infection
|
11.4%
4/35 • Number of events 4 • 2 years
|
|
Injury, poisoning and procedural complications
Seroma
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Investigations
Ejection fraction decreased
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/35 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Hypofractionated Radiation Therapy
n=35 participants at risk
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Hypofractionated Radiation Therapy: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
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|---|---|
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General disorders
Edema limbs
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
General disorders
Localized edema
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Seroma
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • Number of events 1 • 2 years
|
Additional Information
Ciani Ellison, MD
Froedtert and the Medical college of Wisconsin
Phone: 414-805-4400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place