0813 Revision

SUMMARY OF CHANGES Amendment 1, Version Date: February 16, 2010 (Broadcast 2/18/10)
RTOG 0813, "Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for

Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients"

Study Chair: Andrea Bezjak, MD; 416-946-2132; andrea.bezjak@rmp.uhn.on.ca

RTOG 0813 has been amended as follows:

Title Page: The Senior Statistician's affiliation was amended to current RTOG standard text and her e-mail address was updated. The Consulting Statistician's affiliation and contact information were updated.

Eligibility Checklist, page 3: Questions 18-20 were reformatted to current RTOG standard text. The corresponding questions in Appendix I, under "About Using Tissue, Urine, and Blood for Research", were reformatted to be consistent.

Section 3.1.5: In the last sentence, the parenthetical phrase, "PTV touching the pleura", was added for clarity. This phrase also was added to the corresponding question (number 8) on page 1 of the Eligibility Checklist.

Section 3.1.9: The timeframe for the required pregnancy test was corrected to "72 hours" to be consistent with question 12, page 1 of the Eligibility Checklist and with Appendix II.

Section 4.1.6 was deleted as this information is provided in Section 10.0, as is current RTOG standard.

Section 5.2.1 was amended to current RTOG standard text.

Section 5.2.2 was amended and Section 5.2.3 was added to amend "Regulatory Pre-Registration Requirements" to current RTOG standard text.

Section 5.3.1: The ITC's e-mail address was updated. This change also was made in Sections 5.3.3, 12.2, and 12.2.1.

Section 6.5: Figure A was added below the 2^nd paragraph (this figure was made available to sites on the RTOG web site at activation of the study). In addition, in the 1^st paragraph, a reference to Figure 2 was added in a parenthetical phrase, "see Figure 2 below".

In the heading of Section 6.9, the word, "Therapy", was added to amend to the heading to current RTOG standard text.

Section 10.0: The phrase, "blood, urine, and tissue, if adequate tissue is available", was added in parentheses for clarity.

Section 10.3.2.1 was added to update the protocol to current Biospecimen Resource standards of storage of blood samples.

Section 12.1: The schedule for the Lung Adverse Event Form (AE) was revised to include a submission at 12 months after the start of SBRT.

Appendix II: Under "Pre-Treatment", the last timeframe was amended from "Within 2 wks prior to registration" to "Within 2 wks prior to treatment". In addition, the timeframes for evaluations required prior to treatment (versus prior to registration) were added for clarity and to be consistent with Section 4.1.

Appendix III: The Karnofsky Performance Scale was deleted, and in the Zubrod Performance Scale table, parenthetical REFERENCES to Karnofsky scores were deleted, as the Zubrod is the performance scale being used in the study.

SUMMARY OF CHANGES Update: May 7, 2009 (Broadcast 5/7/09)
RTOG 0813, Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for

Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

Study Chair: Andrea Bezjak, MD, 416-946-2132, andrea.bezjak@rmp.uhn.on.ca

At the request of the RTOG Biospecimen Resource and the Translational Research Co-Chair, Dr. Kong, the logistics for submission of specimens in RTOG 0813 have been updated as follows:

Section 10.0: In the 3^rd paragraph the location of the Biospecimen Resource was corrected to University of California San Francisco (vs. "in San Francisco).
Section 10.1.1.1: The word, "preferred", was added after "tissue block of tumor" as information for sites.
Section 10.1.2.4: In the "Note", the temperature was corrected from -20° to -80° C.
Section 10.1.3: "Mailing Address" was clarified to "U.S. Postal Service Mailing Address", and "DHL" was updated to "UPS" in the Courier Address. These changes also were made in Appendix VI.
Section 10.3.1: A note was added to inform sites that a blood collection kit can be obtained from the Biospecimen Resource. This information also was added in Appendix VI. In addition, the timeframe in the 1^st bulleted item was clarified from "Within 3 days of…" to "Within 3 days before delivering the first dose of SBRT".
Section 10.3.2 was updated to clarify that the Specimen Transmittal Form must document the date of collection of plasma and buffy coat, as well as serum.
Section 10.3.3: Blood samples for translational research will be sent to the RTOG Biospecimen Resource rather than to Dr. Kong. The shipping address and contact information for questions were updated accordingly in this section and in Appendix VI.
Section 10.4: In the 2^nd column, "Specimens collected when", the timeframes for collection of urine and blood were clarified from "Within 3 days of…" to "Within 3 days before the first dose of SBRT". This clarification also was made in Appendix VI.
Section 10.5: The last 3 paragraphs referring to submission of blood samples to Dr. Kong were deleted, and the remaining text regarding reimbursement and confirmation of appropriate materials was reorganized for clarity.
Appendix VI:

The 2^nd sentence regarding disposal of the Plug Kit was deleted to update the appendix to current Biospecimen Resource standard text.
In the 2^nd paragraph under "Shipping instructions for urine specimens", the 2^nd sentence was corrected to "Specimens should be shipped only Monday through Wednesday…"
In the "Notes" under "Shipping instructions for urine specimens", the phrase, "and there is sufficient ice for shipment" was added as an instruction to sites.
The mailing address under "Shipping instructions for urine specimens" was deleted as unnecessary.

SUMMARY OF CHANGES Update: February 2, 2009 (Broadcast 2/2/09)
RTOG 0813, Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for

Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

Study Chair: Andrea Bezjak, MD, 416-946-2132, andrea.bezjak@rmp.uhn.on.ca

RTOG 0813 has been updated as follows:

Section 5.2.2 was deleted as inclusion of this text in a non-drug trial is unnecessary. The former Section 5.2.2.2 was appropriately renumbered as Section 5.2.2.

The fax number for submission of the daily treatment record (T5) was updated on the Schema page under "All Sites Note: and in Sections 6.6 and 12.1.