For Protocol Amendment 3 of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases

Transcription

1 For Protocol Amendment 3 of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NCI/Local Protocol #: NRG-BR001/NRG BR001 NCI Protocol Version Date: November 13, 2015 (Broadcast: December 28, 2015) Document The version date was updated for this amendment. Footer Document This amendment was added. History table To provide clarification and address previous irradiation with larger fraction sizes, the following changes were made to the bulleted list: Bullet 1: (delivered in 3 Gy/fraction) was added after 40 Gy Bullet 2: (delivered in 3 Gy/fraction) was added after 50 Gy Bullet 3: (delivered in 3 Gy/fraction) was added after 45 Gy Bullet 4: (delivered in 3 Gy/fraction) was added after 50 Gy Bullet 5: Whole l replaced L at beginning of item and (delivered in 3 Gy/fraction) was added after 30% Bullet 6 is new: Primary tumor irradiated with SBRT Bullet 7 is new: Metastasis irradiated with SBRT First paragraph under Figure 2, a typographical error was corrected: GTV was replaced with PTV To provide clarification, the following text was added: Paragraph 2, sentence 1: ending at L2 was added after spinal canal To clarify information about GTV coverage, the following text was added: Paragraph 5, new sentence 4: Every effort should be made to cover 100% of the GTV by the prescription dose at the lower end of acceptable variation. Table 6-6, row 4, under heading Parallel Organ: This row was deleted as this is unlikely to apply to metastases To correct a typographical error and provide clarity, the following changes were made: Sentence 2: was corrected to Sentence 3: In second occurrence of doses the s was removed. prescribed to the PTV replaced in the tables 6.8 Paragraph 2, sentence 2,was deleted because there cannot be a single metastasis, as there must be between 2 and 4 for eligibility. Text removed is: If the initial case at the institution treats a single metastasis with SBRT, the institution will also be required to submit their first multiple metastases case to be treated with SBRT for pre-treatment review PRIOR TO DELIVERING ANY PROTOCOL TREATMENT. i NRG-BR001 version date 11/13/15

2 For Protocol Consent Amendment 3 of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NCI/Local Protocol #: NRG-BR001/NRG BR001 NCI Protocol Version Date: November 13, 2015 (Broadcast: December 28, 2015) Header What is the usual approach to my breast, lung or prostate cancer? What extra tests and procedures will I have if I take part in this study? The version date was updated for this amendment. Sentences 3 and 4 were removed to provide clarity, as they are repetitive with sentences 1 and 2. This section has been removed, because these tests are standard of care when treating these locations. 2 NRG-BR001 version date 11/13/15

3 For Protocol Amendment 2 of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NCI/Local Protocol #: NRG-BR001 NCI Protocol Version Date: September 29, 2014 (Broadcast: October 6, 2014) Document Footer and Title Pages The version date was updated for this and this amendment was added to the Document History table. No other protocol changes were made. (See Summary of s for Protocol Consent for Amendment 2). For Protocol Consent Amendment 2 of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NCI/Local Protocol #: NRG-BR001 NCI Protocol Version Date: September 29, 2014 (Broadcast: October 6, 2014) Header My signature agreeing to take part in the main study The version date was updated for this amendment. At the request of the CIRB, and any additional studies where I circled yes was deleted because it is not applicable to this protocol.

4 For Protocol Amendment 1 of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NCI/Local Protocol #: NRG-BR001 NCI Protocol Version Date: September 19, 2014 (Broadcast: October 6, 2014) Title pages The statement This trial is sponsored by the National Cancer Institute (NCI) and will be led by NRG Oncology was added per current CTEP requirements Amendment 1 was added to the Document History table. Because the toxicity of delivering SBRT to multiple metastases in close proximity to prior conventionally fractionated EBRT volumes is not known, the guidelines for avoiding overlap of protocol treatment SBRT isododes with prior fractionated external beam volumes were removed from and incorporated in the ineligibility requirements in All subsections were appropriately renumbered Table 6-6: The volume for bile duct was corrected from < 0.3 cc to < 0.03 cc. Table 6-7: The volume for skin was corrected from < 0.3 cc to < 0.03 cc The last two sentences were revised/added for clarity. Appendix I: Assessments in Follow-Up Sample Informed Consent Hgb was added as a recommended collection days after completion of SBRT if clinical symptoms of anemia on physical exam post-treatment are present. The left margin of the table was re-adjusted, The version date on the first page was updated for this amendment. No other changes were made.

5 For Protocol Update of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NCI/Local Protocol #: NRG-BR001/NRG-BR001 NCI Protocol Version Date: May 5, 2014 (Update broadcast: 8/4/2014) Title page The clinicatrials.gov number was added. On the 2 nd title page, the broadcast dates of activation and this update were added to the Document History table This paragraph was updated for clarity A credentialing note was added for clarity The first sentence was updated to include > 6MV First sentence, heterogeneity was added for clarity Under Spinal and item d, 3 rd bullet: 2cm was updated to 1cm Item b under High-Dose Spillage was updated for clarity. 6.5 The 2 nd paragraph was updated for clarity. Table 6-5 was updated 6.5.2, These sections were updated to correspond with Table rd paragraph, the reference to the table was updated. Table 6-6 was updated for clarity This section was updated for clarity.

6 For Protocol Update of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NCI/Local Protocol #: NRG-BR001/NRG-BR001 NCI Protocol Version Date: May 5, 2014 (Update broadcast: 6/3014) Global Due to the transition to the National Clinical Trials Network Radiation Therapy Oncology Group, RTOG Headquarters, and RTOG were replaced with NRG Oncology or deleted, as appropriate, throughout the protocol. Title pages On the 2 nd title page, the broadcast dates of pre-activation and this update were added to the Document History table. Schema A note was added per current standard text. Eligibility The checklist was removed from the protocol and will be available on the website. Checklist 1.3 This 2 nd paragraph was updated for clarity. 3.1 This section was updated to current standard text. 5.1 This section was updated to current standard text and a table. Subsequent sections were appropriately renumbered. RPC was changed to IROC Houston per current standard text In the 2 nd paragraph, Cooperative group was changed to NRG Oncology per current standard text. The subsequent paragraphs were updated to current standard text In the 2 nd paragraph, the parenthetical phrase, RTOG and CTSU Sites, was deleted to update the section to current standard text. In the 3 rd paragraph, the 1 st bulleted item was updated to current standard text. In the 4 th paragraph, the last bulleted item was deleted to update the section to current standard text. 6.0 Clarifying text was added to describe pre-treatment reviews in the 2 nd note. The 3 rd paragraph starting with All metaseses must was updated to correspond with section , RPC was changed to IROC Houston The last paragraph was updated for clarity The 3 rd paragraph in this section was simplified and moved to the 2 nd paragraph. The paragraph was updated for clarity RPC was changed to IROC Houston per current standard text. 6.5 The table was updated for clarity The website link was updated The reference to section 5.2 was changed to section The RTOG website was deleted to update the section to current standard text This section was updated to current standard text The table was updated to current standard text The website link was updated A grammatical error was corrected in the 1 st paragraph, last sentence. i

7 For Consent Update of: NRG-BR001, A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NCI/Local Protocol #: NRG-BR001/NRG-BR001 NCI Protocol Version Date: May 5, 2014 (Update broadcast: 6/3014) Who will see my medical information? Radiation Therapy Oncology Group was replaced with NRG Oncology. ii