The accrual goal has been increased to enroll 1379 patients (previously 1260 patients). In addition, the number of randomized patients has increased to 1241 from 1134.

Sections 11.2 and 113

The second paragraph under Section 11.2 has been relocated as the first paragraph of Section 11.3.

Section 11.6 Statistical Analysis

This new section reads: "Standard survival analysis methods such as the logrank test and Cox regression model will be applied to analyze the treatment effect on time to the development of second primary tumor. The proportional hazard assumption will be examined and proper transformation on the covariants will be applied if necessary. The statistical analysis will be carried out both with and without inclusion of the 107 patients who were affected by the error in the randomization process. The statistical analysis will be based on the intent to treat method.

Also, the last revisions from MDACC did not mention changes made to the Consent Form. A new paragraph was added:

"This clinical research may involve unforeseeable risks to unborn children; therefore, the participants should practice adequate methods of birth control throughout the period of their involvement in the clinical study if they are sexually active. To help prevent injury to children, the female participants should refrain from breast feeding during participation in the clinical research study."

This was included in the replacement pages sent at that time (4/22/96).

Replacement pages are attached.