Activated
RTOG 1106/ACRIN 6697, “Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)”

Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at:   http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=8927                    

Forms for this study also are available on the RTOG web site at: http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1106&mode=html&ptid=383        

In addition, see ACRIN’s attached memo to RTOG sites. Institutions can access ACRIN’s credentialing criteria and material at: http://www.acrin.org/PROTOCOLSUMMARYTABLE/PROTOCOL6697.aspx

Regulatory Notes: NCI policy requires that the "Version Date" of the protocol reflect the date that the protocol was submitted by RTOG to NCI; therefore, the version date and the activation date on the protocol title page are not the same. The "Update Date" (the same as the activation date) indicates that administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes that can be accessed at 

IRB review of an update is not required; however, these changes must be reported to site IRBs.

Activated

RTOG 1174 (ANZGOG 0902/GOG-0274), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial”

Closure
Effective immediately, RTOG 0831, “A Randomized, Double-Blinded, Placebo-Controlled Phase III Trial To Evaluate The Effectiveness Of A Phosphodiesterase 5 Inhibitor, Tadalafil, In Prevention Of Erectile Dysfunction In Patients Treated With Radiotherapy For Prostate Cancer [Prevention of Erectile Dysfunction Study (PEDS)],” is closed to patient accrual, as the study has met its accrual objective. (Notice of this closure was broadcast on Friday, January 27, 2012 and on Monday, February 6, 2012.)

Reminder: Data collection and site IRB renewal for closed studies must continue until the study is terminated.

Please notify your affiliates that are not on e-mail.

- CCOP_RFP_announcement_16Feb2012.pdf
 

Amended and Updated
RTOG 0920, “A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer”

Amendment 5: Eligibility Criteria have been amended to include patients with clinical stage T4a disease.

Update: The demographic portion of the Eligibility Checklist and Sections 5.4 and 7.2 were updated.

Sites can access the complete summaries of changes for the amendment and update at            http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=6443   

Sites can download a copy of the protocol for IRB review at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=4674                       
 

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 of the amendment and update are provided in the Document History table on the 2nd title page of the protocol.

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days.  RTOG recommends re-consenting patients per the site’s local IRB policy. Sites must submit IRB approval for the amendment to CTSU. IRB review of an update is not required; however, these changes must be reported to site IRBs.
 

Attached is the Winter 2012 issue of the newsletter for RTOG 0539, “Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas.”

RTOG has received the attached safety reports from NCI for ABT-888      

RTOG has received a safety report for DASATINIB. 

RTOG has received safety reports for GANITUMAB (AMG-479). 

The following study has been endorsed by the Radiation Therapy Oncology Group and its Gastrointestinal Cancer Committee:

CALGB 80803, “Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer”

RTOG Co-Chair: Theodore S. Hong, MD; 617-724-1159; tshong1@partners.org

Enrollment procedures and data collection for this study must be done via the Clinical Trials Support Unit (CTSU). The enrolling investigator must be a CTSU member investigator. Investigator registration, credentialing information, and the protocol can be accessed at http://www.ctsu.org

RTOG institutions that enter patients on any CTSU trial can receive credit toward RTOG membership accrual requirements. The enrolling investigator must declare RTOG membership at the time of registration in order to receive RTOG credit.

Please notify your affiliates who are not on e-mail.
 

Closure
RTOG 0232, “A Phase III Study Comparing Combined External Beam Radiation And Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone For Selected Patients With Intermediate Risk Prostatic Carcinoma,” will close to patient accrual at 5 PM EST today, February 8, as the study has met its accrual objective. (Notice of this closure was broadcast originally on Wednesday, January 25.)

Reminder: Data collection and site IRB renewal for closed studies must continue until the study is terminated.

Please notify your affiliates that are not on e-mail.

Closure Update
RTOG 0831, “A Randomized, Double-Blinded, Placebo-Controlled Phase III Trial To Evaluate The Effectiveness Of A Phosphodiesterase 5 Inhibitor, Tadalafil, In Prevention Of Erectile Dysfunction In Patients Treated With Radiotherapy For Prostate Cancer [Prevention of Erectile Dysfunction Study (PEDS)]”

Please be advised: RTOG 0831 has accrued 230 patients. This study will close to accrual immediately after 240 patients have been accrued.

Reminder: Data collection and site IRB renewal for closed studies must continue until the study is terminated.

Please notify your affiliates that are not on e-mail.
 

Amended and Re-opened to Patient Accrual
RTOG 0524, “A Phase I/II Trial Of A Combination Of Paclitaxel And Trastuzumab With Daily Irradiation Or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery For Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer" has been amended and re-opened to patient accrual (temporary suspension of accrual to assess the results of a protocol-specified interim toxicity analysis was broadcast on October 26, 2011).

Amendment 8: In response to a CTEP Request for Amendment (RA), the protocol was revised to reflect changes to the Comprehensive Adverse Events and Potential Risks List (CAEPR) for Trastuzumab. Other revisions were made in Sections 6, 7, and 13.

Amendment 9: Includes revisions in the sample consent under “Will my medical information be kept private” and “Where can I get more information”.

See the complete summaries of changes for the amendments at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=7648

Sites can download a copy of the protocol for IRB review at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=4638

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.
 
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If the amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients per your local IRB policy. Sites must submit IRB approval for the amendments to CTSU.

Please notify your affiliates that are not on e-mail.
 

RTOG has received the attached safety reports from NCI for ABT-888      

RTOG has received safety reports from NCI for BEVACIZUMAB      

Closure Notice
RTOG 0831, “A Randomized, Double-Blinded, Placebo-Controlled Phase III Trial To Evaluate The Effectiveness Of A Phosphodiesterase 5 Inhibitor, Tadalafil, In Prevention Of Erectile Dysfunction In Patients Treated With Radiotherapy For Prostate Cancer [Prevention of Erectile Dysfunction Study (PEDS)],” will close to patient accrual at 5 PM EST Friday, February 17, as the study has met its accrual objective.

Reminder: Data collection and site IRB renewal for closed studies must continue until the study is terminated.

Please notify your affiliates that are not on e-mail.
 

Amended
RTOG 0913, “Phase I/II Trial of Concurrent RAD001 (Everolimus) with Temozolomide/Radiation Followed By Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma”

Amendment 1: The trial was amended to utilize the criteria recently proposed by the Response Assessment in Neuro- Oncology (RANO) working group; corrections were made concerning PT/INR and tissue collection; and other clarifications were made throughout the protocol.

See the complete summary of changes at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=6445

Sites can download a copy of the protocol for IRB review at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=4672

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.
 
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If the amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients per your local IRB policy. Sites must submit IRB approval for the amendments to CTSU.

Amended and Updated
RTOG 0929, “A Randomized Phase I/II Study of ABT-888 in Combination With Temozolomide in Recurrent (Temozolomide Resistant) Glioblastoma”

Amendment 6: In response to a CTEP Request for Amendment (RA), the protocol was revised to reflect changes to the Comprehensive Adverse Events and Potential Risks List (CAEPR) for Velibarib (ABT-888). Other protocol corrections and clarifications were made.

Amendment 7: Clarifications were made concerning post-surgery and pre-registration MRI scans.

Update: The eligibility checklist was corrected per an Amendment 6 change.

See the complete summary of changes for the amendments at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=6435

Sites can download a copy of the protocol for IRB review at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=7868

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. The "Update Date" indicates that editorial/administrative changes were made to the protocol. IRB review of an update is not required; however, these changes must be reported to site IRBs..
 
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If the amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients per your local IRB policy. Sites must submit IRB approval for the amendments to CTSU.
 

Closure Notice
RTOG 0232, “A Phase III Study Comparing Combined External Beam Radiation And Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone For Selected Patients With Intermediate Risk Prostatic Carcinoma,” will close to patient accrual at  5 PM EST Wednesday, February 8, as the study has met its accrual objective.

Reminder: Data collection and site IRB renewal for closed studies must continue until the study is terminated.

Please notify your affiliates that are not on e-mail.
 

RTOG # 1114

Phase II CNS Lymphoma

Form Revision

The following form for this study has been revised.   Download the new version from the RTOG web site at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1114&mode=html&ptid=383 The edition code for case report forms is found in the lower right corner of the form.