Trial Outcomes & Findings for A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall (NCT NCT01819831)

NCT ID: NCT01819831

Last Updated: 2023-08-23

Results Overview

To report the number of participants with late radiation morbidity Late subcutaneous fibrosis and joint stiffness are assessed using the European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group (EORTC/RTOG) late toxicity scoring criteria below: Subcutaneous tissue: Grade 1(slight fibrosis; subcutaneous fat loss), Grade 2(moderate fibrosis: slight field contracture), Grade 3(severe fibrosis; field contracture \>10%), Grade 4(necrosis), Grade 0 (none) Joint stiffness: Grade 1(mild stiffness; slight range of motion loss), Grade 2(Moderate stiffness, pain, range of motion loss), Grade 3(Severe stiffness, pain, range of motion loss), Grade 4(necrosis; complete fixation), Grade 0 (none) Lymphedema is measured according to the criteria of Stern: Score 0(none), Score 1(Mild but definite swelling), Score 2(Moderate), Score 3(Severe, considerable swelling), Grade 4(Very severe (skin shiny \& tight)

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

at 2 years from the start of radiation treatment

Results posted on

2023-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Preoperative Proton Radiation Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Preoperative Proton Radiation Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preoperative Proton Radiation n=6 Participants Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: at 2 years from the start of radiation treatment

Outcome measures

Outcome measures
Measure	Preoperative Proton Radiation n=6 Participants Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Late Radiation Toxicities at 2 Years From the Start of Radiation Treatment	0 Participants

SECONDARY outcome

Timeframe: 6 months

This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for reporting of adverse events.

Outcome measures

Outcome measures
Measure	Preoperative Proton Radiation n=6 Participants Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Grade 3-5 Adverse Events at 6 Months From the Start of Radiation Treatment.	0 Participants

SECONDARY outcome

Timeframe: 6 months

Prespecified patterns of failure, including local failure, regional failure, distant failure, and death without disease progression at 6 months from the start of radiation treatment measured by CT or MRI scan

Outcome measures

Outcome measures
Measure	Preoperative Proton Radiation n=6 Participants Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Patterns of Failure at 6 Months From the Start of Radiation Treatment	1 Participants

SECONDARY outcome

Timeframe: 6 months

Patterns of failure including local failure, distant failure, distant-disease-free survival, disease-free survival, overall survival rates, and second primary tumor at 6 month from the start of radiation treatment on CT or MRI scan.

Outcome measures

Outcome measures
Measure	Preoperative Proton Radiation n=6 Participants Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Patterns of Failure at 6 Months distant-disease-free survival	5 participants
Patterns of Failure at 6 Months disease-free survival	5 participants
Patterns of Failure at 6 Months overall survival	6 participants
Patterns of Failure at 6 Months local failure	0 participants
Patterns of Failure at 6 Months distant failure	1 participants
Patterns of Failure at 6 Months second primary tumor	0 participants

SECONDARY outcome

Timeframe: 6 months

Wound complications - Major wound complications, such as secondary operations, re-admissions, and/or invasive procedures for wound complication (deep wound packing and/or prolonged dressing changes) due to Infection, dehiscence.

Outcome measures

Outcome measures
Measure	Preoperative Proton Radiation n=6 Participants Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Wound Complication Rates Infection, Dehiscence at 6 Months From the Start of Radiation Treatment.	1 Participants

SECONDARY outcome

Timeframe: at 2 years

To report the number of participants with late radiation morbidity using quality of life survey including physical, emotional, social/family and functional well-being.

Outcome measures

Outcome measures
Measure	Preoperative Proton Radiation n=5 Participants Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Report of Late Radiation Morbidity at 2 Years	5 Participants

Adverse Events

Preoperative Proton Radiation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Preoperative Proton Radiation n=6 participants at risk Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation. proton radiation: proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions) surgery (wide local excision; limb preservation surgery): In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Infections and infestations dehiscence	16.7% 1/6 • Number of events 1 • At 6 months and 2 years post-enrollment.

Other adverse events

Adverse event data not reported

Additional Information

Gary Yang, Professor, Chair of Radiation Medicine

Loma Linda University Health

Phone: 909 558 4444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place