Cover Page - Dr. Hanson is no longer at an RTOG institution and was deleted as co-study chair.
Section 7.3.5- The phone and fax numbers for Neli Giofreda at Searle are (847) 506-8740 and (847) 506-8761. Unused tablets will be returned to Searle.
10/22/98 A new supply of Misoprostol is available and accrual can resume effective immediately.IMPORTANT NOTICE! 10/13/98 The Misoprostal study 9607 is temporarily closed for lack of drug availability.
#3
SUMMARY OF CHANGES
RTOG 96-07 Misoprostol
May 13, 1998
The following correction is in effect:
Section 6.2.1 deleted "...during the first week of radiation..." to fit with Section 12.1.
All amendments to this study must be submitted to your IRB for approval
#2
SUMMARY OF CHANGES
RTOG 96-07 Misoprostol
January 21, 1998
The following changes are in effect:
Eligibility Checklist
a) Three additional questions were added after Q18 to verify eligibility
b) Whether any component of the patient's care was given at a VA or military facility will also be requested at registration
Section 1.2, paragraph 3, line 5 "versus placebo" was deleted.
Section 5.1
Patients may not be registered onsite via modem for this study; misoprostol cannot be shipped for any patient registered by this method.
Section 7.0The RTOG's IND number was added (IND #54,684)