SU2C-SARC032 Protocol
A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity (SU2C-SARC032)
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
Protocol requirement
Please fill out the credentialing status inquiry form to let us know that you would like to participate on this protocol.
Institutions that were previously credentialed to participate in another protocol will be notified if any additional credentialing steps are required.
As a participant in the SU2C-SARC032 study, it is required that your institution be monitored by the IROC Houston.
- Please complete and submit a demographics form if you are not currently monitored by the IROC Houston QA Center.
- Each institution will receive OSLD for their megavoltage photon beams if it is not already being monitored by IROC Houston QA Center.
Data to be submitted per patient
External Beam Radiation Therapy
Please submit the following:
- Complete SU2C-SARC032 IROC Data Submission Form
- Daily Treatment Records
- Pre-treatment MRI (T1 weighting + gadolinium contrast & T2 weighting)
- Post-radiation therapy/pre-operative MRI
- Planning CT scan, in DICOM format
- DICOM RT Structure Set
- DICOM RT Plan File
- DICOM RT Dose Files
- Complete post-treatment SU2C-SARC032 IROC Daily IGRT Shift Form, therefore only one completed form per patient.
- DICOM Spatial Registration File for IGRT (if available)
Brachytherapy
Please submit the following:
- Planning CT scan, in DICOM format with catheters in-situ.
- DICOM RT Structure Set
- DICOM RT Plan File
- DICOM RT Dose Files
- Daily Treatment Records
- Treatment plan reports for each insertion, PDF file to include source activities, dwell times, dwell positions and isodose lines
Data Submission
There are several different ways that data can be sent to the IROC Houston. DICOM and non-DICOM data can either be
- burned to a CD and snail mailed
- sent electronically via OneDrive
- To gain access to OneDrive folder please email jlowenst@mdanderson.org to request access to a shared folder.
- Please create a folder with the patient case number within OneDrive shared folder. Once you have submitted the data, please email the IROC Houston, and in the subject, please write SU2C-SARC032 Patient ID ______ so that we are aware that the data is available for review.
Contact
Email: IROCHouston@mdanderson.org
Mail:
Attn: Jessica Lowenstein
IROC Houston QA Center
8060 El Rio Street
Houston, TX 77054
U.S.A.
Phone: 713-745-8989
Fax: 713-794-1364