Medical University of South Carolina
Charleston, South Carolina, 29401, United States
Location status: Recruiting
Location contact
Jennifer Harper, MD
CONTACT
NCT Number: NCT06905132
The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Charleston, South Carolina, 29401, United States
Location status: Recruiting
Jennifer Harper, MD
CONTACT
This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day Hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive preoperative 5-day HFRT (30Gy/5fx once daily over consecutive weekdays) followed by "standard of care" wide local excision 2-6 weeks later.
Time frame: 6 months
Evaluate the safety of 5-day HFRT as measured by the rates of major wound complications occurring within 120 days of surgery.
Time frame: 6 months
Evaluate treatment response to 5-day HFRT as measured by pathologic response. Pathologic response is defined as percent necrosis and percent viable tumor.
Time frame: 6 months
Evaluate the safety profile of 5-day HFRT, specifically the proportion of patients experiencing acute toxicities and late toxicities
Time frame: 3 years
Estimate 3-year local control rate of 5-day HFRT
Time frame: 3 years
Estimate 3-year relapse-free survival. Relapse-free survival is defined as the time from surgery to disease recurrence or death from any cause. 3-year overall survival of 5-day HFRT
Time frame: 3 years
3-year overall survival of 5-day HFRT. Overall survival is defined as the time from RT initiation to death from any cause.
Contact information is provided by the study sponsor or research team.
Medical University of South Carolina
Other
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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