ALL PRINCIPAL INVESTIGATORS/NURSES/DATA MANAGERS RE: PROTOCOL GOG-0233 ACRIN 6671, REVISION # 9 & #10

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1 TO: FROM: ALL PRINCIPAL INVESTIGATORS/NURSES/DATA MANAGERS LEAH MADDEN PROTOCOL SECTION DATE: JUNE 27, 2011 RE: PROTOCOL GOG-0233 ACRIN 6671, REVISION # 9 & #10 Protocol Title: Utility of Preoperative FDG-PET/CT Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced Carcinoma of the Cervix (IB2, IIA 4 cm, IIB-IVA) or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serious Papillary Carcinoma, Clear Cell Carcinoma, or Carcinomsarcoma (Any Grade); and Grade 1 or 2 Endometrioid Endometrial Carcinoma With Cervical Stromal Involvement Over in Clinical Examination or Confirmed by Endocervical Curettage), for NCI review. NCI Version 6/9/11 GOG Study Chair: Michael Gold, M.D. michael.gold@vanderbilt.edu ACRIN Study Chair: Mostafa Atri, M.D., Dip., Epid. Mostafa.atri@uhn.on.ca IRB Review Recommendation: ( ) No review required ( ) Expedited review; however, site IRB requirements take precedence (X) Full board review recommended because there have been modifications to the eligibility criteria and consent. Please direct questions about the recommended level of IRB review to your local IRB. The local IRB is responsible for making this determination. If your local IRB does not agree with the GOG s recommended level of review, please document the IRB s decision, and the rationale for the decision, in your study files In addition to routine updates for grammar and consistency, Amendment #9 & #10 addresses feedback from the participating sites, introduces an imaging-guided biopsy, clarifies that the sites need to submit primary cancer biopsy stained slides as well as reports for retrospective GOG review, and clarifies that two central reader studies will be performed. Additionally, changes have been made in response to CTEP s mandate to convert all CTCAE v3.0 studies over to CTCAE v4.0 by a certain date. The changes are to inform

2 PAGE 2 the site that all reports through AdEERS should be made using the CTCAE v4.0 criteria, however all toxicities reported on the T form should still be submitted using CTCAE v3.0. The following changes become effective : Cover Page Address information for Dr. Michael Gold, MD, has been updated. Amendment 10 and version date June 11, 2011, have been added. Table of Contents Page numbers were adjusted to match the current version. Schema: Cervical Cancer, Page 5 FDG has been added to clarify use of the agent with the pre-operative diagnostic PET/CT. Schema: Endometrial Cancer, Page 6 FDG has been added to clarify use of the agent with the pre-operative diagnostic PET/CT. The description for hysterectomy has been revised to: Hysterectomy (total abdominal, total laparoscopic, or laparoscopic assisted vaginal hysterectomy),. Section 5.1.1, Cervical Cancer Inclusion Criteria, Page 16 Sites are required to submit biopsy tissue for centralized, retrospective evaluation at GOG. The following language has been added All patients must have had appropriate surgery for cervical carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage. Section 5.1.4, Cervical Cancer Inclusion Criteria, Page 16 Creatinine clearance has been revised to glomerular filtration rate (GFR) and should be completed within 28 days prior to the FDG-PET/CT for the trial. Section 5.1.7, Cervical Cancer Inclusion Criteria, Page 16 Has been added for consistency between disease site-specific eligibility criteria. Section , Cervical Cancer Exclusion Criteria, Page 17 Patient weight limit will be determined by site-specific PET/CT scanner weight limits. Section 5.3.1, Endometrial Cancer Inclusion Criteria, Page 17 Sites are required to submit biopsy tissue for centralized, retrospective evaluation at GOG. The following language has been added All patients must have had appropriate surgery for endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.

3 PAGE 3 Section 5.3.4, Endometrial Cancer Inclusion Criteria, Page 17 Creatinine clearance has been revised to GFR and should be completed within 28 days prior to the FDG-PET/CT for the trial. Section , Endometrial Cancer Exclusion Criteria, Page 18 Patient weight limit will be determined by site-specific PET/CT scanner weight limits. Section 8.1, Pathology Evaluation Prior to Pelvic and Abdominal Lymph Node Sampling, Page 21 1 st bullet, new-2 nd sentence: Unless biopsy is positive on a non-image guided biopsy, an image-guided biopsy or lymphadenectomy would be required, as applicable. This amendment introduces image-guided biopsy as a study-related procedure. Section , PET/CT Identification of Advanced Disease, Page 25 New-Section has been introduced with the new study-related image-guided biopsy requirement. Section 9.1, Patient Entry & Registration Visit, Pages rd bullet: Pregnancy test should be conducted as applicable (see Section for full description in the Eligibility Criteria). 4 th bullet: Creatinine clearance has been revised to glomerular filtration rate (GFR) and should be completed within 28 days prior to the FDG-PET/CT for the trial. 7 th bullet: Language has been added to describe the need to submit slides and reports from the initial biopsy for centralized, retrospective GOG histologic confirmation. Section 9.2, Visit 1: FDG PET/CT, Page 28 Header and section contents have been revised to specify that the diagnostic PET/CT will use the FDG agent. Section has been introduced to describe imaging-guided biopsy. Section 9.6, Visit 5: 6 Months after Visit 1, Page 29 2 nd bullet: CT scan or PET/CT should be completed at 6 months if image-guided biopsy returned negative results. Section 9.9, Study Procedures Timetable: Cervical Cancer, Page 31 1 st row, 3 rd column: FDG has been added to specify that the diagnostic PET/CT will use the FDG agent. 3 rd row, 1 st column: Language has been added to describe the need to submit biopsy slide and report to GOG for histopathologic confirmation.

4 PAGE 4 8 th row, 1 st column: Creatinine clearance was revised to GFR and should be confirmed (within 28 days prior to FDG-PET/CT). Former-9 th row, 1 st column: Has been deleted as it was repetitive. Now-11 th row, 1 st column: FDG has been added to specify that the diagnostic PET/CT will use the FDG agent. New-13 th row, additions in 1 st and 4 th columns: Imaging-Guided Biopsy (if Suspicious Lesion Found on PET/CT and Initial Biopsy Is Negative has been added prior to surgery at Visit 2. Now-16 th row, 1 st column: CT should also be performed at 6 months after Visit 1 after imaging-guided biopsy. Section 9.10, Patient Entry & Registration Visit, Page 32 3 rd bullet: Pregnancy test should be conducted as applicable (see Section for full description in the Eligibility Criteria). 4 th bullet: Creatinine clearance has been revised to glomerular filtration rate (GFR) and should be completed within 28 days prior to the FDG-PET/CT for the trial. 7 th bullet: Language has been added to describe the need to submit slides and reports from the initial biopsy for centralized, retrospective GOG histologic confirmation. Section 9.11, Visit 1: FDG PET/CT, Pages Header and section contents have been revised to specify that the diagnostic PET/CT will use the FDG agent. The requirement for Visit 1 to be completed within 7 days of registration has been removed. Section has been introduced to describe imaging-guided biopsy. Section 9.14, Visit 5: 6 Months after Visit 1, Page 33 2 nd bullet: CT scan or PET/CT should be completed at 6 months if image-guided biopsy returned negative results. Former-Section 9.16, Visits 13 18: Every Month for 3 Additional Years after Visit 12 Per Standard of Care, Page 33 Has been deleted. Follow up in the endometrial group will end after 2 years. Now-Section 9.16, Study Procedures Timetable: Endometrial Cancer, Page 34 1 st row, 3 rd column: FDG has been added to specify that the diagnostic PET/CT will use the FDG agent.

5 PAGE 5 3 rd row, 1 st column: Language has been added to describe the need to submit biopsy slide and report to GOG for histopathologic confirmation. 8 th row, 1 st column: Creatinine clearance was revised to GFR and should be confirmed (within 28 days prior to FDG-PET/CT). Former-9 th row, 1 st column: Has been deleted as it was repetitive. Now-11 th row, 1 st column: FDG has been added to specify that the diagnostic PET/CT will use the FDG agent. New-13 th row, additions in 1 st and 4 th columns: Imaging-Guided Biopsy (if Suspicious Lesion Found on PET/CT and Initial Biopsy Is Negative has been added prior to surgery at Visit 2. Now-16 th row, 1 st column: CT should also be performed at 6 months after Visit 1 after imaging-guided biopsy. Former-8 th column: Has been deleted as Visits 13 through 18 have been removed for the Endometrial cohort. Section 11.0, Data Collection Forms, Pages New-rows 3 and 5 have been added to describe the pathology forms needed for submission of pathology report and stained slides from the primary cancers. Added below footnotes of table the following, This study utilizes the Common Terminology Criteria for Adverse Events version 3.0 Section 12.1, FDG PET/CT Imaging, Page 40 Header: FDG has been added to specify that the diagnostic PET/CT will use the FDG agent. Section 12.2, Central Reader Study, Page 46 1 st paragraph: Descriptions for the current protocol version s study objectives have been revised to define that a one central reader study will be conducted for the listed study objectives. New-4 th paragraph: Has been added to clarify that A second centralized reader study will be conducted on the Combidex MR component of the trial as described in Amendment 1 through 7 of the protocol. Section 16.1, Page 49 Removed reference to NCI CTCAE v3.0.

6 PAGE 6 Section 16.8, Page 56 Added two paragraphs under Expedited Reporting of Adverse Events occuring 30 Days of the Surgical Procedure : 1 st paragraph specifies CTCAE v. 3.0 utilized from study activation until June 30, nd paragraph states CTCAE v.4.0 will be utilized beginning July 1, 2011 and provides website locations. Following the table a new section has been added: GOG CRF Forms Section 16.83, Page 56 Information on AML/MDS has been added (two paragraphs). Section , Page Information has been updated on reporting when internet connectivity is unavailable. Section , AdEERS Reports Recipients: AdEERS Reports to the Following, Page Header updated for style consistency. Contact information for NCI/CIP and ACRIN recipients has been updated. Section , Page 58 Second paragraph has been added regarding the mapping of adverse event reporting. Appendix I, Clinical Staging Carcinoma of the Cervix Uteri, FIGO Classification, Pages Content has been replaced with updated FIGO Classification criteria from Appendix II, Clinical Staging Carcinoma of the Corpus Uteri, FIGO Classification, Page 74 Content has been replaced with updated FIGO Classification criteria form Appendix III, Sample Consents for Research Study, Template #1: Cervical Cancer, Pages Color has been added to the Header to help sites identify that two templates are provided, one for Cervical Cancer and one for Endometrial Cancer. Page 76, under Before you being the study, 4 th bullet: Reference to checking kidney health has been added. Under During the study, new-2 nd bullet: Has been added to describe the imagingguided biopsy.

7 PAGE 7 Page 77, Overview table, 3 rd row, 2 nd column:, including your kidney health has been added. Overview table, 5 th row, 3 rd column: ; an imaging-guided biopsy may be needed to make sure there is no more disease, only if previous results are negative. Overview table, 9 th row, 2 nd column:, or was negative on imaging-guided biopsy has been added as it impacts 6-month CT scan. Pages 78 to 79, new-sections What Is an Imaging-Guided Biopsy? and Are There Risks Associated with an Imaging-Guided Biopsy? : Have been added to describe this new study-related procedure and its associated risks., Appendix III, Sample Consents for Research Study, Template #2: Endometrial Cancer, Pages Color has been added to the Header to help sites identify that two templates are provided, one for Cervical Cancer and one for Endometrial Cancer. Page 86, under Before you being the study, 4 th bullet: Reference to checking kidney health has been added. Under During the study, new-2 nd bullet: Has been added to describe the imagingguided biopsy. Page 87, Overview table, 3 rd row, 2 nd column:, including your kidney health has been added. Overview table, 5 th row, 3 rd column: ; an imaging-guided biopsy may be needed to make sure there is no more disease, only if previous results are negative. Overview table, 8 th row, 2 nd column:, or was negative on imaging-guided biopsy has been added as it impacts 6-month CT scan. Overview table, final row: Has been deleted; follow up ends after 2 years in the Endometrial Cancer cohort only. Pages 88 to 89, new-sections What Is an Imaging-Guided Biopsy? and Are There Risks Associated with an Imaging-Guided Biopsy? : Have been added to describe this new study-related procedure and its associated risks. Please update all copies of the protocol at your institution with these changes. Do not discard the old version. Please retain a copy of earlier versions of the protocol in your regulatory binder as historical documentation.

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