#6

SUMMARY OF CHANGES

RTOG 95-08 Brain Mets/SRS November 13, 2000


In June 2000, an interim analysis was performed for the RTOG Data Monitoring Committee and 15% of the patients with solitary metastases randomized to SRS did not receive SRS. Patients that are randomized to SRS, but do not receive SRS will be analyzed in the SRS arm, but reduce the observable difference. In order to maintain at least 80% power to detect a 75% difference in median survival than 188 patients (94 patients per arm) with solitary metastases will be required.

The following sections are affected: the Schema and Section 13.2.





#5

SUMMARY OF CHANGES

RTOG 95-08 Brain Mets/SRS June 14, 1999


In an interim analysis for the RTOG Data Monitoring Committee in January 1999, it was found that 10% of patients with solitary metastasis randomized to SRS did not receive SRS. In order to account for the reduced number of solitary metastasis patients actually receiving SRS, then 85 solitary metastasis patients per arm will be required. This adjusted sample size is required to maintain at least 80% power to detect a 75% difference in median survival. Forty six additional patients with a solitary brain metastasis will be required.

The following sections are affected:

The Schema, the Eligibility Checklist, Sections 3.1, 4.2 and 13.2 paragraph 3 (new).

REFERENCES to multiple lesions remain in the treatment sections for those patients randomized prior to this amendment.





#4

SUMMARY OF CHANGES

RTOG 95-08 Brain Mets/SRS September 8, 1998


The following correction was made:

Consent Form (p.17) - The paragraph about pathology submission was deleted. Pathology review was dropped by the March 17, 1998 revision (#3).





#3

SUMMARY OF CHANGES

RTOG 95-08 Brain Mets/SRS March 17, 1998


The following changes are in effect:

Cover Page Dr. Sperduto’s fax number was updated; Dr. Andrews’ address was added.

Eligibility Checklist (p.2) Added

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

Section 1.0 (p.3) the last paragraph was moved to Section 6.2.5.2. on page 6.

Section 6.2 (third bullet) Added “The physician submitting the film . . .”

Section 6.4 Sections 6.4.1-7 were rewritten for consistency.

Section 10.1 An additional case credit for pathology submission is not available. This section was deleted (also affects Section 12.1)

Section 12.1 Followup forms (F1 & MS) will be done annually beginning at year 3 rather than at year 5.

Section 13.3 A table for estimated gender and minority accrual was added.





#2

SUMMARY OF CHANGES
RTOG 95-08 Brain Mets/SRS March 7, 1997


The following changes are in effect:
Dr. Sperduto can also be reached at (612) 442-6000.

The correct phone number for Dr. Schell is (716) 275-5261.





#1

SUMMARY OF CHANGES
RTOG 95-08 Brain Mets/SRS August 16, 1996


The following changes are in effect:

Eligibility Checklist (Q5) Change "surgery" to "complete resection."

Section 6.2.4

6.2.4.2 Stereotactic CT or MRI slice thickness may not exceed 5 mm

Section 6.2.6.3 Added sentences 2 and 3

"The data should be . . . additionally reported."

Section 11.1 History and Neuro Exam are also done at 6 and 12 months

(per Section 11.2.1)

Appendix I (p. 17, Risks) The risks of radiosurgery are more clearly defined

Replacement pages are attached.