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SUMMARY OF CHANGES

RTOG 98-09 PPS

October 26, 1999

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The following changes are in effect:

Cover Page E-mail addresses were added

Schema Deleted “Not registered to another RTOG study” to comply with Section 3.0.

Eligibility Checklist (Q12) – The correct response is “no”.

Schema and Eligibility Checklist The stratification cells were corrected.

Section 4.0 Added

4.4 Baseline CBC, PT, and PTT prior to randomization.

Section 7.1 The FDA - issued IND number is 58,974.

Section 7.3.1 The total daily doses were added for clarity (also affects Appendix I, Description of Procedures, line 6).

Section 7.3.2 Added

“Patients who experience a clinically significant drop in Hgb, Hct, or platelets will discontinue protocol treatment.”

Section 7.3.5 Added

“CBC, PT, and PTT will be performed weekly during the first month after randomization.”

Section 11.5 Section 11.5.1 and 11.5.3 are new. Sentence 2 in Section 11.5.2 was added. “Monthly clinical assessments will include assessments of patient condition, drug tolerance, and response to treatment.”

Appendix I a) Description of Procedures, Paragraph 3 – The first sentence was reworded to include monthly assessments.

b) Risks and Discomforts – added after “. . . bleeding tendency.”

“My clotting rate will be measured . . . . until I stop taking the study capsules”.