SUMMARY OF CHANGES
Amendment 4, Version Date: April 14, 2008
(Broadcast 4/21/08)

RTOG 0514, "Establishment of A Head And Neck Cancer Tissue/Specimen Bank"

Study Chair: Randal S. Weber, M.D., 713-792-6920, rsweber@mdanderson.org


Sites submitting the required fresh, flash frozen specimens (tumor or premalignant tissue and normal tissue) will now receive 1.0 case credit in addition to the per-case reimbursement. Sites submitting fresh, flash frozen normal tissue and a paraffin-embedded tissue block of tumor (versus fresh, flash frozen tumor tissue) will now receive 0.5 case credit in addition to the per-case reimbursement. Section 10.1 was amended to reflect these changes.

The former RTOG Tissue Bank has been relocated and re-named. RTOG 0514 was amended throughout to replace REFERENCES to the "RTOG Tissue Bank" with "RTOG Biospecimen Resource". In addition, Section 1.2 was amended with the new location of the Biospecimen Resource, and contact information for the Biospecimen Resource was added in Sections 10.5.3, 12.2, and in Appendix IV.

In addition, the name of the Head and Neck Cancer Tissue/Specimen Bank was amended to Head and Neck Tissue/Specimen Repository to make it consistent in the protocol title and throughout the protocol text.

Other Changes:
Title page:
Schema page:

Eligibility Checklist, Step 2: At the top of the page, a sentence directing sites to Section 5.2 for details of Step 2 registration was added.

Section 1.3: The first paragraph was amended to clarify that the majority of patients are expected to be subsequently enrolled on an active RTOG study and to make this section consistent with Section 13.2. This clarification also was made in a "Note" added to the first paragraph of Section 5.2.1.

Section 2.1: The name of the Director of the Biospecimen Resource, Dr. Waldman, was added, replacing "Elizabeth Hammond".

Section 3.1.5: The phrase, "prior to submission of specimens" was added for clarity. This change also was made in question 6 on page 1 of the Eligibility Checklist.

Section 5.2.1: The second and third paragraphs were added to clarify Registration-Step 2.

Appendix I: Under "Who can answer my questions about the study?", the web address for the information sheet in the last paragraph was updated.





SUMMARY OF CHANGES
Amendment 3, Version Date: August 28, 2006

RTOG 0514, "Establishment of A Head And Neck Cancer Tissue/Specimen Bank"

Study Chair: Randal S. Weber, M.D., 713-792-6920, rsweber@mdanderson.org


RTOG 0514 has been amended as follows:

RTOG sites have provided feedback that the specimen collection and submission instructions in the protocol were repetitive and confusing as written. Therefore, the text was reorganized for clarity as follows:
Other Changes
Title page: The contact information for the Study Chairs was reformatted to current RTOG standard; the contact information itself was not changed.

Index page: Appendix IV was deleted (as the text from this appendix was incorporated into Section 10.0), and the subsequent appendices were appropriately renumbered.

Schema page: In the third paragraph, the phrase, “and Appendices V and VI” was deleted, as all text regarding submission of specimens is now in Section 10. In addition, the second sentence was amended to read, “Optional specimens (see Section 10.2) also are submitted” to be consistent with changes in Section 10.

Eligibility Checklist, page 2, Step 1: Question 17 of this demographic portion of the checklist was amended to be consistent with the optional specimens described in Section 10.

Section 10.1, “Required Specimens”: In the table, the number of specimens (e.g., “2 samples of”) was deleted, as these details are provided in Section 10.3. In addition, the fourth row was amended to clarify that sites should only submit a paraffin-embedded block if the site is unable to submit the required fresh, flash frozen tissue.

Section 10.2, “Optional Specimens”: Peripheral blood and saliva were made optional versus required specimens (buccal scrapings have always been optional). In addition, as optional specimens are not useful to researchers without the patient’s tissue, the first paragraph of the section was amended to clarify that sites should not submit blood, saliva, or buccal scrapings without the required tissue specimens or in place of the required tissue specimens. Also, the first row of the table in this section was amended to clarify that sites will be reimbursed for blood, saliva, or buccal scrapings, if the required tissue specimens are submitted. In addition, in the second row, the phrase, “purple top”, was added after “anticoagulated blood (EDTA)” for clarity; this change also was made in Section 10.4.1.

Section 10.5.3: The contact information for the RTOG Tissue Bank was updated in this section and in Section 12.2 and Appendix IV.

The following changes were made to Section 10.8 to update this section to current RTOG Tissue Bank standard text:
In addition, in the second sentence of Section 10.8.2, the phrase, “unless the patient has consented to storage for future studies”, was deleted, since patients agreeing to participate in RTOG 0514 are consenting to storage for future studies.

The following changes were made to Appendix I, the sample consent:
Appendix IV: In the list of items included in the specimen kit, the last bulleted item was corrected from “Fed-Ex shipping label” to “ Pre-paid return shipping label”.

An amended protocol is available on the RTOG Web site, www.rtog.org





SUMMARY OF CHANGES
Amendment 2, Version Date: April 4, 2006

RTOG 0514, "Establishment of A Head And Neck Cancer Tissue/Specimen Bank"

Study Chair: Randal S. Weber, M.D., 713-792-6920, rsweber@mdanderson.org


RTOG 0514 has been amended as follows:
Certain active RTOG studies, such as RTOG 0234, are requesting specimens from post-treatment recurrent tumors, and these specimens may be submitted via RTOG 0514. Therefore, Section 3.1.2 of 0514 was added to clarify that patients with biopsy proven recurrent cancer at the primary site are eligible for the study. (Section 3.1.1 was amended to include text from the previous Section 3.1.2.) "Patient Population" on the Schema page was amended to be consistent with Section 3.1.2, and question #3 on page 1 of the Eligibility Checklist was added; subsequent questions were appropriately renumbered. In addition, a "Note" was added to Section 10.5.2 requesting that institutions clearly indicate the type of specimen and the collection time frame on the Specimen Transmittal Form.

Other Changes

The contact information for LDS Hospital was updated in Sections 10.5.3, 12.2, and in Appendix V.

Title page: Dr. Hammond's email address was updated.

Section 10.3.2: The last sentence of the third paragraph was deleted as it was deemed unnecessary.

Section 10.3.3: A sentence was added under the heading to clarify that sites will collect and submit these specimens on every patient consented to the study.

Sections 10.3.3.1 and 10.3.3.2: In the first sentence of these sections, the phrase, "or prior to treatment" was added after "prior to biopsy/surgery". In some cases, patients will have a biopsy/surgery after initial diagnosis, but in some cases, they will not. For the latter patients, blood and saliva is collected prior to treatment.

Section 10.3.3.3, "Required Specimens", was re-numbered as Section 10.4 to make this important section more evident. Section 10.3.3.4, "Optional Specimens", was accordingly re-numbered as Section 10.4.1, and subsequent sections were appropriately renumbered. In addition, in the third paragraph of the Schema page, the reference to "Section 10.3.3" was amended to "Section 10.4" to be consistent with these changes.

In the newly re-numbered section, 10.4, "Required Specimens", a phrase concerning processing of the anticoagulated and the whole blood in the sixth and seventh row of the table was added for clarity. In addition, a note was added below the table to more clearly state that sites that submit the required fresh, flash frozen specimens receive 0.5 case credit, as well as per case reimbursement.

Section 10.7: In the heading, "and Case Credit" was deleted. In the second paragraph the phrase "and 0.5 case credit will be assigned" was deleted. These changes were made because this information is now more clearly presented in Section 10.4.

Section 10.8.2: The last sentence of the paragraph was amended to specify disposition of all the types of specimens, if the patient withdraws consent.

Appendix I, sample consent: Under "What will happen if I take part in this research study?", the last paragraph concerning cell lines was deleted at the request of several RTOG institutions.

Appendix IV: The heading was amended to "Tissue/Specimen Collection Instructions". This change also was made on the Index page. In addition, in the section titled, "Peripheral Blood, Saliva and Other Surrogate Materials", the phrase, "kept refrigerated", was corrected to "stored at the appropriate temperatures".

An amended protocol is available on the RTOG Web site, www.rtog.org





SUMMARY OF CHANGES
Update: February 7, 2006

RTOG 0514, "Establishment of A Head And Neck Cancer Tissue/Specimen Bank"

Study Chair: Randal S. Weber, M.D., 713-792-6920, rsweber@mdanderson.org


RTOG 0514 has been updated as follows:

Title Page: Added Dr. Ridge's e-mail address.

NOTE: This is an editorial/administrative change to the protocol. NCI now requires that these changes be documented on the protocol title page with the date of the update noted as "Update Date."

An updated protocol is available on the RTOG Web site, www.rtog.org





SUMMARY OF CHANGES
Amendment 1, Version Date: November 1, 2005

RTOG 0514, "Establishment of A Head And Neck Cancer Tissue/Specimen Bank"

Study Chair: Randal S. Weber, M.D., 713-792-6920, rsweber@mdanderson.org


RTOG 0514 has been amended as follows:

Section 3.1.1: The word, "untreated" was deleted so that patients with recurrent head and neck cancer are now eligible for the study. This change also was made on the Schema page under "Patient Population" and on page 1 of the Eligibility Checklist, Question 1.

Section 5.1.1: The sixth paragraph was added to update the section to current RTOG standard and to refer sites to RTOG web support for assistance with web registration.

The following changes were made to provide sites with clearer and more complete procedures for collection and submission of specimens:

Section 8.2.1: The second paragraph was amended, deleting a "note" under the third bulleted item and adding a "NOTE" under the second and fourth bulleted items. In addition, the sentence, "The entire sample will be snap frozen", was added to the third bulleted item.

Section 10.3.2: The phrase "oriented on edge" was added to the first sentence of the third paragraph. The fourth paragraph was amended to be consistent with Section 8.2.1.

Section 10.3.3.2: A sentence was added to the second paragraph referring sites to details of collection and submission provided in the specimen collection kit.

Appendix IV:

The paragraph titled "For salvia collection" was amended.

Appendix V:



An amended protocol is available on the RTOG Web site, http://www.rtog.org