Status:
ACTIVE_NOT_RECRUITING
Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Resectable Soft Tissue Sarcoma
Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of su...
Detailed Description
PRIMARY OBJECTIVES: I. To determine, in patients with localized, resectable soft tissue sarcoma, whether there is a non-inferior major wound complication rate for patients receiving 42.75 Gy in 15 fr...
Eligibility Criteria
Inclusion
- Tumor located in the soft tissues of the extremities or superficial trunk
- Deemed a candidate for complete macroscopic resection of the primary sarcoma
- Histologically confirmed sarcoma arising in soft tissue
- Patient may have had excisional biopsy of all gross disease at an outside facility with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon in the participating institution recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of neoadjuvant irradiation (a sandwich approach of marginal excision--\>radiation therapy(RT)--\> wide excision, as per our standard practice)
- No evidence of nodal or distant metastases as determined by clinical examination or any form of imaging
- Has provided written informed consent for participation in this trial
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Life expectancy greater than 6 months
- Patients capable of childbearing are using adequate contraception
- Available for follow-up
Exclusion
- Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma. In other words, treatment on this trial would require re-irradiation of tissues
- Patients with nodal or distant metastases
- Women who are pregnant
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2027
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03819985
Start Date
December 17 2018
End Date
August 31 2027
Last Update
September 5 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030