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DATE: February 4, 2005
SUBJECT: RTOG P-0014, closure & termination
CLOSURE AND TERMINATION
RTOG P-0014, “A Phase III Randomized Study of Patients With High Risk, Hormone-Naïve Prostate Cancer: Androgen Blockade with 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy,” will close to patient accrual at the end of business today, February 4, 2005, as the study has not met its accrual objectives.
Additionally, all study activity and data collection will cease at the end of business today, and the study should be terminated at your local IRB. Any data received after this date will be returned. Physicians should notify patients of this decision, and patient treatment should continue per physician standard of care.
To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: August 25, 2004
SUBJECT: Forms Revision Notice - RTOG 0014 - A Phase III Randomized Study of Patients with High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade with 4 Cycles of Immediate Chemotherapy vs. Androgen Blockade with Delayed Chemotherapy
Forms Revision
Phase III Prostate
RTOG 0014
The following forms for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/p0014/main.html. The edition code for case report forms is found in the lower right corner of the form.
| Form Type | New Version Code/Date |
| F1 Follow-Up Form | F1a | 8-25-04 |
| I1 Initial Follow-Up Form | I1a | 8-25-04 |
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Changes Made: F1: Minor formatting and instructions clarification throughout.
"0 Not Applicable" added to code tables Q3, Q8A, Q8B, Q8C, Q13B.
Q12 Attribution code table changed.
Q13 and Q14 Formatting changes, treatment code tables expanded to include generic hormones.
Q15 Formatting changes, treatment code table expanded to include new chemotherapy regimens.
I1: Minor formatting and instructions clarification throughout.
Q3 Another Malignancy - Added code table, report invasive malignancy only.
Added "0 Not Applicable" to code table for Q4-Q8.
Added new question Q12 T-stage.
Added new question Q13 N stage.
Subsequent questions renumbered: Q12 became Q14, Q13 became Q15, Q14 became Q16 and individual items assigned question numbers 17, 19 and 20.
Added new question 18 Distant Metastases.
Renumbered questions: Q15 became Q21, Q16 became Q22.
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Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received on or after 9-13-04 will be returned to the site for transcription.
Sheryl Mitnick, RTOG Data Management
Please note that effective April 15, 2004 RTOG no longer mails a forms packet on new registrations. Forms for all open studies and many of our closed studies are available on the RTOG web site. If the form you need is not available on our web site, you may request one by calling 215-574-3191 or you may fax your request to 215-574-0300.
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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