OUTBACK Protocol

Please fill out the credentialing status inquiry form to let us know that you would like to be credentialed for 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 OUTBACK study it is required that your institution be monitored by the IROC Houston.

• Please complete and submit a on line demographics form, if you are not currently monitored by the IROC Houston.

• Each institution will receive OSLD for their megavoltage photon beams if you are not already being monitored as part of your membership in an NCI-sponsered cooperative study group.

• For International Institutions:

o   If your institution is not a member of an NCI funded clinical trial group you will need to submit all data to ANZGOG directly.

o   If your institution is a member of an NCI funded clinical trial group you will need to submit all data directly to the IROC Houston.

External Beam Radiation Therapy:

Please submit the following: (Data Submission Check List)

• Complete Case Report Form (CRF)

• Portal Films

• Daily treatment records

• DVH in color with all of the critical structure displayed

• Treatment plan including isodose distribution through the center of the treatment volume

• Beams Eye Views of each field

• All dosimetry calculations

• A completed online External Beam Summary Form

Brachytherapy:

Please submit the following:

• Complete Case Report Form (CRF)

• Simulator films (include magnification factors), digitally reconstructed radiographs(DRRs), CTs, MRIs or US images with applicator in-situ for each intracavitary placement. If providing DRRs please provide an AP and Lateral view in order for us to be able to determine point A and B dose. Please see the file linked here which explains exactly what views are needed in order for us to be able to determine the bladder and rectal doses.

• Treatment plan to include source activities, dwell times, dwell positions and isodose lines

• A completed online Gynecological Brachytherapy Protocol Compliance Form

Data Submission:

• For International Institutions:

o   If your institution is not a member of an NCI funded clinical trial group you will need to submit all data to ANZGOG directly.

o   If your institution is a member of an NCI funded clinical trial group you will need to submit all data directly to the IROC Houston.

• For United States Institutions, you will need to submit all data directly to the IROC Houston.

There are several different methods that data can be sent to the IROC Houston:

• A hard copy of the data can be sent via snail mail or converted to pdf and emailed to the IROC Houston.

• CTs, MRIs and US images can either be burned to a CD and snail mailed or can be sent electronically through the IROC Houstons ftp site.

• If films are taken for brachytherapy they can be sent via snail mail or electronically as long as a magnification factor can be determined. Without a magnification the IROC Houston is unable to perform a recalculation of brachytherapy dose.

Important Information