Study on Preoperative vs Postoperative Radiation Therapy for Soft Tissue Sarcoma in Limbs and Trunk
Sponsor: Mount Sinai Hospital, Canada
ClinicalTrials ID:NCT02565498
This clinical trial is comparing the effects of giving radiation therapy before or after surgery in patients with soft tissue sarcoma in the limbs or trunk. The study aims to see if there are differences in wound healing complications between the two approaches.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is investigating whether giving radiation therapy before surgery (preoperative) or after surgery (postoperative) leads to similar short-term wound healing outcomes in patients with soft tissue sarcoma in the limbs or trunk. Half of the participants will receive radiation therapy before surgery, and the other half will receive it after surgery. The goal is to determine which approach results in fewer complications related to wound healing.
Description
In treating soft tissue sarcoma (STS) of the limbs and trunk, radiation therapy (RT) combined with surgery is a common approach. However, there is debate about whether radiation should be given before or after surgery. Both methods offer similar control over the cancer, but preoperative radiation may reduce long-term side effects like tissue stiffness and swelling compared to postoperative radiation. This difference may be due to the lower radiation dose used before surgery (50 Gy) compared to after surgery (60-66 Gy), and the smaller area treated preoperatively. Concerns about preoperative radiation include the risk of delayed wound healing. Newer techniques like image-guided intensity-modulated radiation therapy (IG-IMRT) may help reduce these risks by precisely targeting the tumor while sparing healthy tissue. This study aims to compare the rates of wound healing complications between preoperative and postoperative radiation in treating STS.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with soft tissue sarcoma in the limbs or trunk, confirmed by a pathologist.
- Suitable for either preoperative or postoperative radiation therapy and surgery, as determined by a radiation oncologist and surgical oncologist.
- The tumor is either a new occurrence or has returned locally. Patients who had a biopsy with positive margins may be eligible after discussion among doctors.
- Have an ECOG performance status score between 0 and 3, indicating varying levels of activity.
- Aged 18 years or older.
- Able to provide informed consent.
- Available for treatment and follow-up appointments.
Exclusion Criteria
- Have a benign (non-cancerous) tumor.
- Have had another cancer within the past five years, except for certain skin or cervical cancers that were treated successfully.
- Have received radiation therapy to the same area before.
- Plan to receive chemotherapy as part of the treatment.
- Have had conservative surgery to the target area.
- Have cancer that has spread to lymph nodes or other parts of the body.
- Have other major health issues that would make it unsafe to participate in the study or follow-up care.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Cleveland Clinic Taussig Cancer Institute | 44195 | Cleveland | Ohio |
| Oregon Health & Science University | 97239-3098 | Portland | Oregon |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.