A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall
When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back. Radiation therapy is frequently used in addition to surgery to reduce the chances of the sarcoma coming back. However, radiation can have long-term side effects on the normal tissues surrounding the tumor, leading to problems such as swelling, scarring, and joint stiffness.
Recently, there have been advances in the way that radiation therapy can be given. Proton radiation therapy is one of those advances. With proton radiation, it is possible to give radiation over a smaller area surrounding the tumor, resulting in less radiation to the surrounding normal tissues.
The purpose of this study is to determine whether proton radiation decreases the long-term side effects of radiation on normal tissues and if smaller proton radiation fields reduce local recurrence compared to the larger radiation fields that have been used in prior studies.
|Soft Tissue Sarcoma||Radiation: proton radiation Procedure: surgery (wide local excision; limb preservation surgery)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall|
- Late radiation toxicities (>grade 2 lymphedema, subcutaneous fibrosis, and joint stiffness) [ Time Frame: at 2 years from the start of radiation treatment ]
- Grade 3-5 adverse events (CTCAE, v4.0) [ Time Frame: 6 months ]
- Composite patterns of failure, including local failure (in-field, marginal, out-of-field), regional failure, distant failure, and death without disease progression [ Time Frame: 6 months ]
- Composite measures of local failure, including local-regional failure, distant failure, distant-disease-free survival, disease-free survival, overall survival rates, and second primary tumor [ Time Frame: 6 months ]
- Wound complication rates [ Time Frame: 6 months ]Infection, dehiscence
- Degree of late radiation morbidity at 2 years with quality of life assessment (FACT-G) [ Time Frame: at 2 years ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2022|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Experimental: 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.
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)
Other Names:Procedure: 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.
Data support preoperative radiotherapy as one of the standard options in the management of large or high-grade extremity soft tissue sarcomas (STS). The advantages of preoperative radiotherapy are lower doses and smaller radiation volumes; these may be used to effect improvement of long-term side effects and extremity function. Another potential advantage is assisting surgery through tumor shrinkage and reduction of tumor cell seeding. The disadvantage of preoperative radiation is the higher likelihood of postoperative wound complications, but in a prospective phase III trial these complications were found to be generally temporary and without significant effect on long term function.
Combined conservative surgery and radiotherapy has shown to achieve excellent local control in sarcoma patients following margin-negative surgery, but late radiation morbidity and reduced quality of life may result from adjuvant radiation. The dosimetric advantage of proton radiotherapy may translate into reduced acute and late effects due to improved normal-tissue sparing in the treatment of extremity and truncal STS. However, these potential advantages need to be validated in clinical trials. The investigators propose a phase II study to evaluate the effect of preoperative proton radiotherapy on the reduction of late radiation morbidity, patterns of failure, and impact of late radiation morbidity on general quality of life (QOL).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819831
|Contact: Proton Referral RN or Gary Y Yang, MD||800-776-8667 or 909-558-4000 ext firstname.lastname@example.org|
|Contact: Proton Referral RN 1st Call 1 800 776-8667 Back-up: Sandi Teichman, RNemail@example.com|
|United States, California|
|Loma Linda University Medical Center / James M. Slater Proton Treatment Center||Recruiting|
|Loma Linda, California, United States, 92354|
|Principal Investigator: Gary Y Yang, MD|
|Principal Investigator:||Gary Yang, MD||Loma Linda University Medical Center|