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SUMMARY OF CHANGES

RTOG 95-13 Topotecan

March 17, 1998

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The following changes are in effect:

Eligibility Checklist (page 2) - Added

Will any component of the patient’s care be at a VA or military facility?

Section 13.2 (and schema) The sample size was increased to 83 patients. Added

An interim analyses of RTOG 95-13 indicates that 64% of the patients are RPA class III and IV.³⁷ These classes may have the best opportunity to show a survival improvement, although this observation should not be excluded in class V and VI patients. In order to have sufficient power to observe a significant improvement in survival, the sample size will be increased to 83 patients to account for the 36% of patients expected in class V and VI.