SUMMARY OF CHANGES Update: August 12, 2008 (Broadcast 8/12/08)

RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery"

Study Chair: Mohan Suntharalingam, MD; 410-328-2331; msuntha@umm.edu

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Title Page: ECOG has endorsed the study. Contact information was added for the ECOG Co-Chair, Bapsi Chakravarthy, MD. ECOG sites will enroll patients via the Cancer Trials Support Unit (CTSU).

Section 6.0: The last sentence was rewritten to clarify that patients will receive radiation prior to chemotherapy on the days that they receive chemotherapy.

Section 7.5

• Heading: The IND # for cetuximab was added.
• First sentence: "and investigator brochure" was added to the first sentence.
• Second sentence: Current information for accessing the brochure was added.
• Last two sentences: Deleted and replaced by changes to the first two sentences.

Section 7.5.7: Contact information was updated for Biologics, Inc.

Appendix I, Sample Consent

• During the study/if you are in group 1/third sentence: The second use of cetuximab was corrected to cisplatin.
• How long will I be in the study/second sentence: "every 4 months indefinitely" was corrected to "every 4 months for 2 years, every 6 months for 2 years, and then every year indefinitely" for consistency with Section 12 of the protocol.

Appendix II, Study Parameters: "for 2 years" was added after "every 4 months from chemo/RT start" for consistency with Section 12 of the protocol.

Note: These are editorial/administrative changes to the protocol. NCI requires that these changes be documented on the protocol title page as "Update Date."





SUMMARY OF CHANGES Update: April 24, 2008 (Broadcast 4/24/08)


RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery"

Study Chair: Mohan Suntharalingam, MD; 410-328-2331; msuntha@umm.edu

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Section 5.2: Regulatory Pre-Registration Requirements were restructured per current RTOG standard. All subsequent sections were renumbered and cross references were updated.

Sections 7.5.6 and 7.5.7 and Appendix V: Drug shipment logistics were revised to reflect that Biologics is the distributor.

Section 7.8.2, 1^st paragraph, last sentence: The sentence, "Any pregnancy occurring on study must be reported as a medically significant event via AdEERs," was added per current RTOG standard.

Appendix VII: The hours for the CTSU patient registration desk were updated.



Note: These are editorial/administrative changes to the protocol. NCI requires that these changes be documented on the protocol title page as "Update Date".