#18

SUMMARY OF CHANGES
Amendment 18, Version Date: March 21, 2008

(Broadcast date: April 15, 2008)

RTOG 9406, A Phase I/II Dose Escalation Study Using Three Dimensional Conformal Radiation Therapy for Adenocarcinoma of the Prostate

Study Chair: James D. Cox, MD, 713-563-2317, jcox@notes.mdacc.tmc.edu


RTOG 9406 has been amended to add follow-up buffy coat cell collection and banking for Single Nucleotide Polymorphisms (SNPs) analysis to the protocol, as follows:

Title page: Contact information for study co-chairs was corrected (in one case, a co-chair had been replaced); a new co-chair was added to handle specimen collection; and all information was corrected and completed to RTOG standard.

Index: An entry for a new appendix containing specimen collection instructions was added to the table of contents.

Section 1.6-1.6.1: Background information regarding SNPs was added.

Section 2.5: Specimen collection was added as an objective.

Section 10.0: A pathology section was added to include information about specimen collection.

REFERENCES: An existing reference was corrected. **REFERENCES cited in new Section 1.0 text were added.

Appendix I: Blood collection consent text was added.

Appendix X: Specimen collection instructions were added.

#17

SUMMARY OF CHANGES

RTOG 94-06 Prostate February 14, 2000


The following changes are in effect:

Cover Page E-mail addresses were added; the participants’ list was updated and moved to Appendix IX (new).

Dose Level Escalation

This dose escalation study was originally designed with three total dose levels: Level I 68.4 Gy, Level II 73.8 Gy and Level III 79.2 Gy; all given at 1.8 Gy per day. After dose level II (disease groups 1 and 2) was shown to be safe and the patient accrual to dose level III (79.2 Gy) had been completed a fourth dose level was added. It was the consensus of the participating investigators to increase the daily fraction size from 1.8 Gy to 2.0 Gy for dose level IV and for any additional dose levels in order to keep the total treatment time at a reasonable level for the patient. Therefore the minimum PTV dose for dose level IV was 74.0 Gy given at 2.0 Gy per day. The preliminary analysis of dose level III shows it to be safe. Dose level IV (for disease groups 1 and 2) has finished accruing and the participating investigators have decided to escalate to one final dose. The minimum PTV dose for dose level V will be 78.0 Gy given at 2.0 Gy per day.

The three disease groups defined by disease extent will be receiving the following dose levels:

Disease Group 1 Dose Level V: 78.0 Gy/ 2.0 Gy per fraction
Disease Group 2 Dose Level V: 78.0 Gy/ 2.0 Gy per fraction
Disease Group 3 Closed to accrual.

Disease group 3 has recently reached its accrual for dose level II and will not be escalated due to slow accrual.

This amendment affects the Schema, Eligibility Checklist (Q7), and Sections 6.1.5-7 (new) and 13.1.4 (new).




#16

SUMMARY OF CHANGES

RTOG 94-06 Prostate October 5, 1998


The following changes are in effect:

Cover Page Dr. Landry replaces Dr. Benton as PI (Emory)

Dose Escalation

Patient accrual to Dose Level III (79.2 Gy) has been completed; however the acceptability of Dose Level III has not yet been determined. It is the consensus of the participating investigators to increase the daily fraction size from 1.8 Gy to 2.0 Gy, total dose 74.0 Gy. This new fraction size is only for patient groups 1 and 2. Patient group 3 will continue to accrue at the 73.8 Gy Dose Level.

The following sections have been amended to reflect this change:

Schema

Section 6.1.4 (new, subsequent sections were renumbered)

Section 13.1.3 (new)

REFERENCES 81 and 82 (new)

All patients registered by 3D-approved participating institutions will therefore be treated as follows:

GROUP 1: 74.0 Gy
GROUP 2: 74.0 Gy
GROUP 3: 73.8 Gy

Note: The T2 form has been updated; please visit the RTOG 3D Quality Assurance Center web site (www.rtog.org) for the current version.




#15

SUMMARY OF CHANGES

RTOG 94-06 Prostate June 17, 1998


The following changes are in effect:

Cover Page

Dr. Kenneth Russell is the new PI at the University of Washington (9856)

New participants were added:

Upstate Carolina CCOP (J. Bearden, M.D.) (2132)

Toledo CCOP (P. Schaefer, M.D.) (8803)

Ohio State University (R. Gahbauer, M.D.) (4101)




#14

SUMMARY OF CHANGES

RTOG 94-06 Prostate March 10, 1998


The following changes are in effect:

Cover Page – additional participants were approved:

Medical College of WI (R. Byhardt, M.D.) (7001)

Ann Arbor Regional CCOP (M. Pilepich, M.D.) (7717)

Correction to #13 (2/2/98) – Dr. Schmidt-Ullrich (1701) is at the Medical College of Virginia, not UVA.

Section 5.1, line 4-change to Appendix VIII; line 6-the Dry Run QA test is described on page 32, section 7a.




#13

SUMMARY OF CHANGES

RTOG 94-06 Prostate February 2, 1998


The following changes are in effect:

Cover Page additional participants were approved for study entries

Allegheny-Hahnemann (B. Micaily, M.D.) (1301)

University of VA (R. Schmidt-Ullrich, M.D.) (1701)

Albert Einstein Medical Center (S. Asbell, M.D.) (5101)

Montefiore Medical Center (B. Vikram, M.D.) (1514)

Western PA Hospital (J. Figura, M.D.) (7008)

Eligibility Checklist, p.2 - Add

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




#12

SUMMARY OF CHANGES

3D/OG 94-06 Prostate November 17, 1997


The following changes are in effect:

Cover Page

Dr. Benton is the new PI for Emory University.

Sections 4.3 and 11.1

Serum testosterone will be done pretreatment and at first followup



Dose Level III for Group 2
(79.2 Gy) has completed accrual





#11

SUMMARY OF CHANGES
3D/OG 94-06 Prostate June 9, 1997

The following changes are in effect:

Dr. Roach replaces Dr. Phillips as 3D PI for UCSF.

Effective immediately, patients will be registered using only your regular RTOG institution number. You will receive $400. reimbursement for each case as of 6/9/97; however, an additional case credit will no longer be offered. The University of Washington will continue to use #9856.





#10

SUMMARY OF CHANGES
3D/OG 94-06 Prostate May 12, 1997

The following change is in effect:

Cover Page

The Mayo Clinic has been approved for this study.





#9

SUMMARY OF CHANGES
3D/OG 94-06 Prostate April 1, 1997

The following clarifications have been made:

Cover Page

Thomas Jefferson University has joined this study.

Section 5.1 The Full Member limitation was dropped.

Section 6/1/3 (p. 8) Group 1: Treatment group was corrected to PTV=CTV1 + 0.5 to 1.0 cm.





#8

SUMMARY OF CHANGES
3D/OG 94-06 Prostate January 24, 1997

The following clarifications have been made:

Cover Page

Dr. Carlos Perez will represent Washington University, replacing Dr. Emami.

Section 5.0 was expanded to include the pre-approval process

Section 6.1 was divided into two sections: one for Dose Levels I and II, and one for Dose Level III

CURRENT DOSE LEVEL STATUS

9851 (UCSF), 9853 (Miami), 9854 (Michigan), 9857 (WI)

Group 1 =

Option 7

79.2 Gy

Group 2 =

Option 8

79.2 Gy

Group 3 =

Option 6

73.8 Gy


9850 (Fox Chase), 9852 (Chicago), 9855 (UNC), 9856 (Seattle),

9858 (St. Louis), 2423 (Davis), 5901 (MDA) and 7501 (Alberta)

Group 1 = Option 4 (closed 8/5/96)
Group 2 = Option 5 (closed 12/24/96)
Group 3 = Option 6
(this is the only option open for this dose level)

All groups: 73.8 Gy


Institution #1523 (Emory)

Group 1 = Option 1
Group 2 = Option 2
Group 3 = Option 3

All groups: 68.4 Gy

Institutions at Dose Levels I and II are encouraged to complete their accrual and dry runs toward their respective next dose levels.

 




#7

SUMMARY OF CHANGES
3D/OG 94-06 Prostate August 5, 1996

The following changes are in effect:

Cover Page

Dr. Cox's new numbers are:

(713) 792-3411 (phone)

(713) 792-3660 (fax)

The University of Alberta has joined the study

The new PI at Emory University is Dr. WilliamThoms

Accrual of Group 1 to Level II (73.8 Gy)is complete.

Institutions treating to that dose may enter only Group 2 and 3 patients.

Institutions accruing at the 68.4 Gy levelmay still enter all three groups.

Note: Data and dosimetry must be submittedexactly as specified in Section12.0. Both RTOG HQ and WU are getting the other'smaterials.

A replacement cover is attached.