Clinical trial NCT05917301: Pre-operative Hypofractionated Proton Therapy
Official title: PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Soft Tissue Sarcoma
Keywords: proton therapy
soft tissue sarcoma
hypofractionated
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Robert L. Sloan Fund for Cancer Research
First posted: 2023-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* Adult patients (≥18 years of age)
* Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
* WHO/ECOG status ≤2

Exclusion Criteria:

* 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
* Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
* Confirmed pregnancy.

Primary outcomes:
measure: Rate of major wound complications
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Incidence of acute grade ≥3 adverse events
timeFrame: 2 years after treatment
measure: Rate of local recurrence free survival
timeFrame: 1 and 2 years after enrollment
measure: Rate of metastasis free survival
timeFrame: 1 and 2 years after enrollment
measure: Rate of late grade ≥2 radiation toxicity
timeFrame: median two year follow up
measure: Musculoskeletal Tumor Rating Scale scores
timeFrame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years
measure: Toronto Extremity Salvage Score (TESS) scores
timeFrame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years
measure: Functional Assessment of Cancer Therapy-General (FACT-G) scores
timeFrame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years
measure: Rate of pathologic complete response
timeFrame: through study conclusion (estimated 5 years from opening)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Curtland Deville, MD
role: PRINCIPAL_INVESTIGATOR
References: