0212 Broadcast DATE: April 6, 2010 SUBJECT: RTOG 0212, 0213, 0214, 0239, 0241: Closed Studies Amended As mandated by CTEP, the following closed RTOG Lung studies have been amended to replace CTC, v. 2.0 with CTEP's Active Version CTCAE (v. 4.0): RTOG 0212, "A Phase II/III Randomized Trial of Two Doses (Phase III-Standard Vs. High) and Two High Dose Schedules (Phase II-Once Vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer" RTOG 0213, "A Phase I/II Trial of A Cox-2 Inhibitor, Celebrex™ (Celecoxib), with Limited Field Radiation for Intermediate Prognosis Patients with Locally Advanced Non-Small Cell Lung Cancer, with Analysis of Prognostic Factors" RTOG 0214, A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation In Patients with Locally Advanced Non-Small Cell Lung Cancer" RTOG 0239, "A Phase II Study of Accelerated High Dose Thoracic Irradiation with Concurrent Chemotherapy for Patients with Limited Small Cell Lung Cancer" RTOG 0241, "Phase I Study of Irinotecan and Cisplatin in Combination with Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients with Limited Stage Small Cell Lung Cancer" Sites can access the complete summaries of change for these amendments as follows: http://www.rtog.org/members/protocols/0212/summary_changes.html http://www.rtog.org/members/protocols/0213/summary_changes.html http://www.rtog.org/members/protocols/0214/summary_changes.html http://www.rtog.org/members/protocols/0239/summary_changes.html http://www.rtog.org/members/protocols/0241/summary_changes.html Sites can download a copy of each protocol for IRB review by accessing the RTOG web site as follows: http://www.rtog.org/members/protocols/0212/0212.pdf http://www.rtog.org/members/protocols/0213/0213.pdf http://www.rtog.org/members/protocols/0214/0214.pdf http://www.rtog.org/members/protocols/0239/0239.pdf http://www.rtog.org/members/protocols/0241/0241.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Please notify your affiliates that are not on e-mail. DATE: May 14, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0212 Web-based Electronic Data Submission Is Now Available For RTOG # 0212 LUNG F1 Follow-Up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry. Web entry will be required for all cases enrolled through RTOG after January 1, 2006. This pertains to case numbers 147 through 267. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after June 15, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, B.A., C.C.R.P. RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 12, 2008 SUBJECT: RTOG 0132, 0212, 0330, and 0615: Updated UPDATED RTOG 0132/ACRIN 6665 (ECOG R0132), "A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (GLEEVEC NSC #716051) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase (CD117) [ACRIN 6665]", (a closed study), Updated: Contact information for Dr. Blanke and for the RTOG Biospecimen Resource RTOG 0212, "A Phase II/III Randomized Trial of Two Doses (Phase III-Standard Vs. High) and Two High Dose Schedules (Phase II-Once Vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer" (a closed study), Updated: The SWOG Co-Chair RTOG 0330, "A Pilot Phase II Study of Pre-Operative Radiation Therapy and Thalidomide (IND 48832; NSC 66847) for Low Grade Primary Soft Tissue Sarcoma or Pre-Operative MAID/Thalidomide/ Radiation Therapy For High/Intermediate Grade Primary Soft Tissue Sarcoma of the Extremity or Body Wall (a closed study)", Updated: Contact information for Dr. Kraybill and for the RTOG Biospecimen Resource RTOG 0615, "A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer", Updated: Question 9 on the Eligibility Checklist Sites can access the complete summaries of changes at: http://www.rtog.org/members/protocols/s0132/summary_changes.html http://www.rtog.org/members/protocols/0212/summary_changes.html http://www.rtog.org/members/protocols/0330/summary_changes.html http://www.rtog.org/members/protocols/0615/summary_changes.html Sites can download a copy of the updated protocols by accessing the RTOG web site at http://www.rtog.org/members/numericactive.html NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; The "Update Date" indicates that editorial/administrative changes were made to the protocol; for clarity, the broadcast date of the update is provided in parentheses on the summary of changes. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. 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 or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: February 12, 2008 SUBJECT: RTOG 0212, Closure Closure RTOG 0212, "A Phase II/III Randomized Trial of Two Doses (Phase III-Standard Vs. High) and Two High Dose Schedules (Phase II-Once Vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer", will close to patient accrual at 5 p.m. EST today, Tuesday, February 12th, as the study has met the protocol specified accrual. (Notice of this closure was previously broadcast on 1/29/08.) Please notify your affiliates that are not on e-mail. 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 or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 29, 2007 SUBJECT: RTOG 0212, Closure Notice Closure Notice RTOG 0212, "A Phase II/III Randomized Trial of Two Doses (Phase III-Standard Vs. High) and Two High Dose Schedules (Phase II-Once Vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer", will close to patient accrual at 5 p.m. EST on Tuesday, February 12th, as the study has met the protocol specified accrual. Please notify your affiliates that are not on e-mail. 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 or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 20, 2006 SUBJECT: Form Revision Notice - RTOG 0212 FORMS REVISION RTOG 0212 Phase II/III Lung: Prophylactic Cranial RT The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0212/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 I1 Initial Evaluation Form I1b 4-20-06 F1 Follow-Up Form F1a 4-20-06 LE LENT SOMA Form LEa 4-20-06 T1 Radiotherapy Summary Form T1a 4-20-06 Changes Made: I1: Changed order of questions. Added date fields and data elements. F1: New question added – Question #9 LE: Added box for brain scoring T1: Question #9 added. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after May 5, 2006 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Wendy Bergantz RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 23, 2006 SUBJECT: Forms Revision Notice - RTOG 0212 FORMS REVISION RTOG 0212 Phase II/III PCI The RTOG Headquarters address listed on the instructions that accompany the follow-up form for patients accrued to this study prior to 01-01-06 has been revised. Download the new instructions from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0212/0212f1.pdf Changes Made: The mailing address for RTOG Headquarters has been updated. Please notify your joint center institutions and affiliates who are not on e-mail. Debora Grant, RN RTOG Data Management DATE: February 09, 2006 SUBJECT: Forms Revision Notice - RTOG 0212 RTOG 0212 Phase II Lung PCI FORMS REVISION The following forms for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0212/0212i1-2006.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1    Initial Evaluation Form I1a     2-9-06   Changes Made: Question 1: Date of Birth changed to age. Question 4: Prior surgery removed. Question 4: RT to head and neck added. Question 11: ANC changed to ACG Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after February 17, 2006 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Deb Grant, RN RTOG Data Management DATE: January 05, 2006 SUBJECT: Forms Revision Notice - RTOG 0212 RTOG 0212 FORMS REVISION Phase III Prophylactic Irradiation for Patients with SCLC 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/0212/main.html The edition code for case report forms is found in the lower right corner of the form.   Form Type Date   I1    Initial Evaluation Form 12-29-05   F1    Follow-Up Form 12-29-05   QL    Quality of Life Questionnaire 12-29-05   Changes Made: These forms were adapted for the Stage III portion of this study. These forms are to be used for those patients registered to the study from 1/1/06 forward ONLY. Continue to use the original forms for patients registered prior to 1/1/06.   Note:  The forms for this study are separated for those patients entered prior to 1/1/06 and for those patients entered from 1/1/06 forward. Please notify your joint center institutions and affiliates who are not on e-mail. Wendy Bergantz RTOG Data Management Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 29, 2005 SUBJECT: RTOG 0212 Amended Amended RTOG 0212, "A Phase II/III Randomized Trial of Two Doses (Phase III-Standard vs. High) and Two High Dose Schedules (Phase II-Once vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer." Amendment 6: The Institut Gustave-Roussy (IGR) is closing its phase III part of the study to patient accrual on December 31, 2005. The phase II North American part of the study will remain open to accrual. The protocol has been amended to address data management and statistical issues after the phase III closure. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0212/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0212/0212.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. 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@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 21, 2004 SUBJECT: RTOG 0212, Amended Amended RTOG 0212 (SWOG 0212/ECOG R0212/CALGB 30305) "A Phase II/III Randomized Trial Of Two Doses (Phase III-Standard Vs. High) And Two High Dose Schedules (Phase II-Once Vs. Twice Daily) For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer", Amendment #5: The ineligibility criteria have been amended to correspond to the revision of the international companion study, PCI 01-EULINT1. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0212/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0212/0212.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. 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@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 27, 2004 SUBJECT: RTOG 0212 and 0241: Revised Revised RTOG 0212 (SWOG 0212/ECOG R0212/CALGB 30305) "A Phase II/III Randomized Trial Of Two Doses (Phase III-Standard Vs. High) And Two High Dose Schedules (Phase II-Once Vs. Twice Daily) For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer", Revision #4: The Cancer and Leukemia Group B (CALGB) is participating in the study. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0212/summary_changes.html RTOG 0241 (CALGB 30202), “Phase I Study of Irinotecan and Cisplatin In Combination With Twice Daily Thoracic Radiotherapy (45 Gy) Or Once Daily Thoracic Radiotherapy (70 Gy) For Patients With Limited Stage Small Cell Lung Cancer”, Revision #5: Section 6.7 was revised to allow for PCI twice daily as well as once daily. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0241/summary_changes.html You may download a copy of each of the protocols for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0212/0212.pdf and http://www.rtog.org/members/protocols/0241/0241.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the revision was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, revisions must be submitted and approved by local IRBs within 90 days. 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@acr-arrs.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 28, 2004 SUBJECT: PROTOCOL NOTICE: RTOG 0122 and RTOG 0212, Updated Updated RTOG 0122, "A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement”, Update: Section 13.5.2 was corrected. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0122/summary_changes.html This updated protocol can be accessed on the RTOG web site at http://www.rtog.org/members/protocols/0122/0122.pdf RTOG 0212, "A Phase II/III Randomized Trial Of Two Doses (Phase III-Standard Vs. High) And Two High Dose Schedules (Phase II-Once Vs. Twice Daily) For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer", Update: In Section 11.4.1, the SWOG contact was updated. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0212/summary_changes.html This updated protocol can be accessed on the RTOG web site at http://www.rtog.org/members/protocols/0212/0212.pdf These updates are editorial/administrative changes to the protocols. NCI requires that these changes be documented on the protocol title page as “Update Date”, not as a revision. IRB review is not required; however, these changes must be reported to site IRBs. 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@acr-arrs.org DATE: December 30, 2003 SUBJECT: PROTOCOL NOTICE: RTOG 0212, Revised Revised RTOG 0212, “A Phase II/III Randomized Trial Of Two Doses (Phase III-Standard Vs. High) And Two High Dose Schedules (Phase II-Once Vs. Twice Daily) For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer”, Revision #3: SWOG and ECOG are participating in the study. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0212/summary_changes.html Regulatory Notes: NCI policy requires that the “Version Date” of the protocol reflect the date the revision was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses next to the version date. You may download a copy of the protocol for IRB review by accessing the RTOG Web site at http://www.rtog.org/members/protocols/0212/0212.pdf When submitting this revision to your IRB (Expedited review is allowed; however, site IRB requirements take precedence), please identify the revision as #3 (12/9/03). After you receive IRB approval of the revision, please fax the approval to the CTSU Regulatory Office at 215-569-0206. 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@acr-arrs.org