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Trial Title:
Pre-operative Hypofractionated Proton Therapy
NCT ID:
NCT05917301
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
proton therapy
soft tissue sarcoma
hypofractionated
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
hypofractionation
Description:
This study is being done to see if hypofractionation in treating sarcoma, will also
provide patients with a faster and safer treatment outcome.
Arm group label:
Pre-operative hypofractionated proton therapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Curtiland Deville, MD
Phone:
202-537-4788
Email:
cdeville@jhmi.edu
Contact backup:
Last name:
Dana Kaplin
Phone:
410-614-3950
Email:
dkaplin1@jhmi.edu
Start date:
April 18, 2024
Completion date:
December 2032
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
Robert L. Sloan Fund for Cancer Research
Agency class:
Other
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05917301
