Trial Summary
What is the purpose of this trial?This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures.
Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.
Do I need to stop my current medications for the trial?The trial protocol does not specify if you need to stop your current medications. However, if you are planned for systemic therapy like chemotherapy, targeted agents, or immunotherapy, you cannot participate in the trial.
Is Hypofractionated Proton Therapy a promising treatment for sarcoma?Yes, Hypofractionated Proton Therapy is promising for treating sarcoma. It can target tumors more precisely, reducing damage to healthy tissues. This means it might improve treatment success and reduce side effects compared to other radiation therapies.1361112
What data supports the idea that Proton Therapy for Sarcoma is an effective treatment?The available research shows that Proton Therapy for Sarcoma can be effective because it targets the tumor more precisely, reducing damage to surrounding healthy tissues. This is important because it can lead to fewer side effects and complications. One study found that Proton Therapy might improve the response of high-grade sarcomas before surgery, which is a positive sign of its effectiveness. Another study compared Proton Therapy to traditional photon therapy and found that Proton Therapy could be more beneficial for treating soft tissue sarcomas in the limbs. This suggests that Proton Therapy could be a better option for some patients compared to other treatments.134811
What safety data exists for hypofractionated proton therapy?Safety data for hypofractionated proton therapy has been reported in several studies. For prostate cancer, a study compared acute adverse event rates between hypofractionated and conventionally fractionated proton therapy, indicating feasibility. In non-small cell lung cancer, a phase 1 trial reported safety data for hypofractionated proton therapy with concurrent chemotherapy, and a phase 2 trial suggested it may allow safe delivery of treatment. Additionally, a study on central lung cancer found high dose hypofractionated proton therapy to be safe and feasible. Overall, these studies suggest that hypofractionated proton therapy can be safely implemented in various cancer treatments.257910
Eligibility Criteria
This trial is for adults (18+) with primary or locally recurrent sarcoma in the limbs or trunk. Participants should be able to perform daily activities with minimal assistance (WHO/ECOG status ≤2).Treatment Details
The study tests if a short course of proton therapy, given in five sessions before surgery, is safe and effective for soft tissue sarcomas of the extremity and trunk. It will assess wound healing and life quality post-treatment.
1Treatment groups
Experimental Treatment
Group I: Pre-operative hypofractionated proton therapyExperimental Treatment1 Intervention
Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.
Hypofractionated Proton Therapy is already approved in United States, European Union, Japan for the following indications:
🇺🇸 Approved in United States as Proton Therapy for:
- Prostate cancer
- Brain tumors
- Spinal cord tumors
- Head and neck cancers
- Retroperitoneal sarcomas
🇪🇺 Approved in European Union as Proton Therapy for:
- Prostate cancer
- Brain tumors
- Spinal cord tumors
- Head and neck cancers
- Eye tumors
🇯🇵 Approved in Japan as Proton Therapy for:
- Prostate cancer
- Brain tumors
- Spinal cord tumors
- Head and neck cancers
- Pediatric cancers
Find a clinic near you
Research locations nearbySelect from list below to view details:
Sibley Memorial HospitalWashington, United States
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
Robert L. Sloan Fund for Cancer ResearchCollaborator
References
Proton therapy for sarcomas. [2014]Sarcomas are a heterogeneous group of tumors that can occur in a wide array of anatomic sites and age ranges with varying histologies. Proton beam therapy, as compared with advanced x-ray radiation therapy techniques, can substantially lower dose to nontarget tissues. This dosimetric advantage can potentially allow for improvement of the therapeutic ratio in the treatment of many of the sarcomas by either increasing the local control, via increased dose to the target, or by decreasing the normal tissue complications, via lowered dose to the avoidance structures. This article reviews the key dosimetric studies and clinical outcomes published to date documenting the potential role proton beam therapy may play in the treatment of sarcomas.
High Dose Hypofractionated Proton Beam Therapy is a Safe and Feasible Treatment for Central Lung Cancer. [2019]There have been few reports about high total dose hypofractionated proton beam therapy for central lung cancer. The aim of this study was to examine retrospectively the safety and efficacy of high total dose hypofractionated proton beam therapy for central lung cancer.
Excellent Pathologic Response and Atypical Clinical Course of High-Grade Extremity Sarcoma to Neoadjuvant Pencil Beam Scanning Proton Therapy. [2020]Neoadjuvant radiation therapy, followed by definitive surgical resection, remains the standard of care for resectable high-grade and unresectable soft tissue sarcomas. Proton therapy offers the promise of highly conformal dose distributions with improved sparing of neighboring normal tissues as compared with conformal and intensity modulated photon techniques. It is unclear whether proton therapy may offer an improved tumoral response, especially with dose escalation, in this relatively radio-insensitive tumor type. We, herein, present a patient with an excellent pathologic response to preoperative pencil beam scanning proton therapy despite a complex treatment course.
Hypofractionated radiotherapy for non-metastatic bone and soft tissue sarcomas. [2019]To evaluate the efficacy and toxicity of hypofractionated radiotherapy in non-metastatic soft tissue and bone sarcomas.
Hypofractionated Proton Therapy with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Phase 1 Trial from the University of Florida and Proton Collaborative Group. [2021]We report the safety data from the first multicenter phase 1 trial investigating the use of hypofractionated proton therapy with concurrent chemotherapy for patients with stage II or III non-small cell lung cancer.
Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection. [2022]There are limited data regarding the use of hypofractionated radiation therapy (RT) for soft tissue sarcoma. We report early oncologic outcomes and wound complications of patients undergoing preoperative hypofractionated (5 fraction) RT followed by immediate surgical resection.
Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. [2022]To confirm the feasibility of hypofractionated proton beam therapy (PBT), we compared the acute adverse event rates and International Prostate Symptom Score (IPSS) in prostate cancer patients treated with hypofractionated versus conventionally fractionated (2.0 Gy relative biological effectiveness (RBE)/fraction) PBT.
Hypofractionated preoperative radiotherapy for high risk soft tissue sarcomas in a geriatric patient population. [2022]Standard therapy for localised, resectable high risk soft tissue sarcomas consists of wide excision and radiotherapy over several weeks. This treatment schedule is hardly feasible in geriatric and frail patients. In order not to withhold radiotherapy from these patients, hypofractionated radiotherapy with 25 Gy in 5 fractions was evaluated in a geriatric patient population.
Chemoradiation with Hypofractionated Proton Therapy in Stage II-III Non-Small Cell Lung Cancer: A Proton Collaborative Group Phase 2 Trial. [2022]Hypofractionated radiation therapy has been safely implemented in the treatment of early-stage non-small cell lung cancer (NSCLC) but not locally advanced NSCLC owing to prohibitive toxicities with photon therapy. Proton therapy, however, may allow for safe delivery of hypofractionated radiation therapy. We sought to determine whether hypofractionated proton therapy with concurrent chemotherapy improves overall survival.
Normofractionated and moderately hypofractionated proton therapy: comparison of acute toxicity and early quality of life outcomes. [2022]Data on the safety of moderately hypofractionated proton beam therapy (PBT) are limited. The aim of this study is to compare the acute toxicity and early quality of life (QoL) outcomes of normofractionated (nPBT) and hypofractionated PBT (hPBT).
Comparing Ultra-hypofractionated Proton versus Photon Therapy in Extremity Soft Tissue Sarcoma. [2023]Recent single institution, phase II evidence has demonstrated the feasibility and efficacy of ultra-hypofractionated, preoperative photon therapy in 5 fractions for the treatment of soft tissue sarcoma (STS). Our purpose was to evaluate the dosimetric benefits of modern scanning beam proton therapy compared with conventional photon radiation therapy (RT) for the neoadjuvant treatment of adult extremity STS.
Dosimetric comparison between proton beam therapy, intensity modulated radiation therapy, and 3D conformal therapy for soft tissue extremity sarcoma. [2023]Proton beam therapy (PBT) may provide a dosimetric advantage in sparing soft tissue and bone for selected patients with extremity soft sarcoma (eSTS). We compared PBT with photons plans generated using intensity-modulated radiotherapy (IMRT) and three-dimensional conformal radiotherapy (3D-CRT).