Download Study Agent Shipment Form

RTOG 0617
CETUXIMAB and/or PACLITAXEL STUDY AGENT SHIPMENT FORM (SASF)
Cetuximab will be provided for both U.S. and Canadian sites/Paclitaxel will only be provided to Canadian sites.
“A Randomized Phase III Comparison of Standard- Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with
Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients with Stage IIIA/IIIB NonSmall Cell Lung Cancer”
A patient-specific supply of the study agent(s) will be shipped by Biologics, Inc., only to institutions that have identified a
single individual as responsible for receipt and accountability of shipments, who have completed and submitted this Study
Agent Shipment Form (SASF). This form should be completed electronically (versus handwritten for improved legibility)
then faxed by U.S. and Canadian Institutions to the CTSU Regulatory Office (Fax 215-569-0206) as soon as the individual
responsible for the study agent has been identified. International institutions must submit the Study Agent Shipment
Form to RTOG headquarters (Fax 215-574-0300) only after receiving written approval of the submitted LOI from
RTOG HQ. NOTE: The SASF requires submission only once. The SASF must be processed before the institution is
approved to receive drug. Institutions should allow adequate time (7-10 days) for form processing before registering the
first case. Patient registration, not submission of the SASF, triggers the initial drug shipment. See Section 7.0 of the
protocol under the “Supply” and “Drug Ordering and Accountability” headings for details regarding anticipated
shipment and delivery timeframes.
Please review Section 5.0 of the protocol to assure that you have met and understand all pre-registration
requirements before calling to register your first case.
(To increase legibility and prevent shipping problems, it is preferred that this form be completed electronically. It can then be printed out for
the Investigator to sign and faxed or mailed to the appropriate entity)
Shipping Information (all information noted in red is required)
Name and Title of Responsible Party
Street Address (No P.O. Boxes)
City, State, Zip Code
Telephone Number
Fax Number
E-mail Address
Cooperative Group Affiliation for
Registration (Please select only one)
RTOG Institution Number
CTEP/NCI Code
Institution Name
Initial IRB Approval Date (mm/dd/yyyy)
CALGB
NCIC
CTSU
NSABP
/
/
Approval Pending
ECOG
RTOG
GOG
SWOG
RTOG HQ Confirmation
Investigator Name
Investigator NCI Number
Investigator Signature
Send completed forms from U.S. & Canadian sites to:
CTSU Regulatory Office
1818 Market Street, Suite 1100
Philadelphia, PA 19103
FAX 215-569-0206
RTOG Headquarters Approval
Version 1/2007
NCCTG
Date
Send completed forms from APPROVED International
sites to:
RTOG HQ
1818 Market Street, Suite 1600
Philadelphia, PA 19103
FAX 215-574-0300
Date