Pre-operative Hypofractionated Proton Therapy
ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years of age)
Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
WHO/ECOG status ≤2
Disqualifiers
History of prior local radiation therapy
Inability to tolerate treatment position for duration of simulation or treatment
Tumor originating in retroperitoneal location
Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy
Trial design
Design model
Single group
Treatments tested in this trial
hypofractionation
RadiationThis study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Pre-operative hypofractionated proton therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of major wound complications
Number of major wound complications as defined by the CAN-NCIC-SR2 trial ("secondary operation under general or regional anaesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), or wound management without secondary operation…\[including\] an invasive procedure without general or regional anaesthesia (mainly aspiration of seroma), readmission for wound care such as intravenous antibiotics, or persistent deep packing for 120 days or longer.")
Time frame
90 days after surgerySecondary outcomes
1
Incidence of acute grade ≥3 adverse events
Rate of acute grade 3 or higher adverse events (CTCAE5)
Time frame
2 years after treatment2
Rate of local recurrence free survival
Number of patients without local recurrence on CT and/or MRI at specified time points.
Time frame
1 and 2 years after enrollment3
Rate of metastasis free survival
Number of patients without metastasis on CT and/or MRI at specified time points.
Time frame
1 and 2 years after enrollment4
Rate of late grade ≥2 radiation toxicity
Rate of grade 2 or higher CTCAE5 adverse events associated with radiation therapy (fibrosis, lymphedema, or joint stiffness).
Time frame
median two year follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Robert L. Sloan Fund for Cancer Research
Collaborator
Source ClinicalTrials.gov