Status:
COMPLETED
A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall
Lead Sponsor:
Loma Linda University
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18-98 years
Phase:
NA
Brief Summary
When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back. Radiation therapy is frequently used in addition to surgery to reduce the chances of the sarcoma coming ba...
Detailed Description
Data support preoperative radiotherapy as one of the standard options in the management of large or high-grade extremity soft tissue sarcomas (STS). The advantages of preoperative radiotherapy are low...
Eligibility Criteria
Inclusion
- Histologically proven primary soft tissue sarcoma of the upper extremity (including shoulder), lower extremity (including hip) or body trunk (excluding retroperitoneum).
- No clinical evidence of distant metastatic disease
- Evaluation by surgeon, with documentation that the tumor is resectable
- ECOG performance status 0-1
- For females of childbearing potential, a serum pregnancy test within 4 weeks prior to registration
- Patient must practice adequate contraception
- Adequate bone marrow function
Exclusion
- Patients with sarcoma of the head, neck, intra-abdominal or retroperitoneal region, hand or foot
- Histopathology demonstrating rhabdomyosarcoma, extraosseous primitive neuroectodermal tumor (PNET), soft tissue Ewing's sarcoma, osteosarcoma, Kaposi's sarcoma, angiosarcoma, aggressive fibromatosis, dermatofibrosarcoma protuberans or chondrosarcoma
- Clinical evidence of regional lymph node or distant metastatic disease
- Prior invasive malignancy (except non-melanomatous skin cancer or early stage prostate cancer) unless disease free for a minimum of 3 years
- Prior radiotherapy to the potential target anatomic region would result in overlap of radiation fields for current sarcoma
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to used medically acceptable forms of contraception
Key Trial Info
Start Date :
February 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01819831
Start Date
February 27 2013
End Date
May 19 2022
Last Update
August 23 2023
Active Locations (1)
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1
Loma Linda University Medical Center / James M. Slater Proton Treatment Center
Loma Linda, California, United States, 92354