#3

SUMMARY OF CHANGES

RTOG 97-09 Pilocarpine April 1, 1999


The following changes are in effect:

Schema Metastases to the neck from an unknown primary are eligible provided the dose to > 50% of the salivary gland is > 50 Gy. This also affects the Eligibility Checklist (Q1) and Section 3.1.1.

Section 3.2.3 Deleted “adrenergic antagonists” (also deleted from the Eligibility Checklist, Q6).

Section 4.1 Requirement that the biopsy must be done within 6 weeks prior to study entry was deleted.

Sections 6.2 and 6.3 Clarified as follows:

6.2 Technique: Salivary glands should be included as part of the treatment field and must be irradiated with opposed photon portals. Wedge-pair techniques that spare mucosa on one side will be excluded except when used to boost the primary tumor.

6.3 Dose: The dose to > 50% of the salivary gland should be > 50 Gy given over 5 to 5 ˝ weeks at 1.8-2 Gy once daily or 1.2 Gy b.i.d. > 6 hours apart, 5 days a week.

Section 7.3.6 McKesson’s address was added.

Appendix VIII The direct fax number is (215) 574-0300.




#2

SUMMARY OF CHANGES

RTOG 97-09 Pilocarpine January 8, 1999


The following changes have been made:

Section 3.2 - Added

Patients receiving concurrent chemotherapy with radiotherapy and/or registered to another RTOG treatment protocol for head and neck cancer ARE eligible. This also affects the Schema and the Eligibility Checklist (Q12 & Q13). Section 3.2.8 and 3.2.9 were deleted.

Section 11.1

A followup CT scan is not required.




#1

SUMMARY OF CHANGES

RTOG 97-09 Pilocarpine September 8, 1998


The following changes are in effect:

Section 3.2 - Added

3.2.8 Concurrent chemotherapy

3.2.9 Patients registered to an RTOG treatment protocol for head and neck cancer.

These changes also affect the schema and the Eligibility Checklist (Q12-13)

Section 6.3 - Changed to

“ . . . central axis midplane minimum dose of 60 Gy over 6-7 weeks . . . 5 days a week” (also affects the Schema)

Section 11.3.2 (last line) Changed to

“Saliva should then collected for 5 minutes.”

Section 12.1 L4 and DP were corrected for text shift.