A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): proton radiation; surgery (wide local excision; limb preservation surgery)
Intervention type(s): Radiation; Procedure
Intervention description(s): proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions); 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.
Other intervention name(s): Proton radiotherapy; Proton treatment; wide local excision; limb preservation surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extremity soft tissue sarcoma; proton radiation; preoperative radiation