#1

SUMMARY OF CHANGES

RTOG 97-13

April 17, 1998

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The following changes are in effect:

Schema Deleted “N0” (typo). Added “Agent will be applied seven days a week”.

Section 4.1.4 Change to “Patient should be lying flat . . .”

Section 7.2 Timing of applications was added. This change also affects the study- specific consent form in Appendix I (Procedures).

Section 7.4.2 Due to a number of difficulties, Médix Pharmaceuticals Americas, Inc. (MPA) can provide only aloe vera gel besides Biafine. Products other than Biafine and aloe vera gel will be the responsibility of the individual institution or patient. This change also affects the study-specific consent form in Appendix I, (Procedures) and the Shipping form (Appendix VII). Specific questions about supply can be directed to Joanna Ogilvie at MPA.

Section 7.4.4 MPA’s new address for this section and for Appendix IV is:

Médix Pharmaceuticals, Americas, Inc. 6301 Ivy Lane Suite 5100 Green Belt, MD 20770 (800) 672-7811 ext. 10 FAX (301) 479-1725
Section 11.3.2 Added “Remember to record the date of the photograph on the B1 Form”.

Section 12.2 Photographs should be taped, not stapled, to the B1 Form.

Section 12.4 and 12.5 Added information about record keeping.

Appendix V Added “seven days a week”

Appendix VI Column 2 was corrected to 9713.