RTOG 0517 Revisions

SUMMARY OF CHANGES Amendment 3, Version Date: September 28, 2007
RTOG 0517, "Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast, and Prostate Cancer"

Study Chair: Michael J. Seider, PhD, MD; 330-375-3557; seiderm@summa-health.org

RTOG 0517 has been amended as follows:

Section 3.2.3: Patients who have undergone prior treatment with Strontium-89 or Samarium-153 for bone metastases are not eligible for this study.

Eligibility Checklist, pp. 1-2:

For consistency with Section 3.2.3, a new question 13 was inserted regarding prior Strontium-89 or Samarium-153 treatment; the original question 13 is now question 14 and the following questions were renumbered.
Question 17 (originally question 16): The incorrect reference to Appendix V was deleted.

Section 1.4.2: Second paragraph, last sentence: The incorrect reference to Appendix IV was deleted.

Section 6.3.4: A typo under the gastrointestinal, CNS, and cardiovascular adverse events was corrected: less than 1% of patients experience the adverse events listed.

SUMMARY OF CHANGES Amendment 2, Version Date: July 25, 2007
RTOG 0517, "Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast, and Prostate Cancer"

Study Chair: Michael J. Seider, PhD, MD; 330-375-3557; seiderm@summa-health.org

RTOG 0517 has been amended as follows:

Eligibility Checklist, pp. 1-2: For consistency with Section 3.1.5, a new question 11 was inserted regarding CyberKnife treatment; the original question 11 is now question 12 and the following questions were renumbered.

Section 3.0

3.1.5: The sentence, "If patients have undergone CyberKnife treatment, treatment must be completed > 14 days prior to registration" was added for clarity.

3.2.1: A "note" was added regarding the eligibility of patients with no evidence of disease in the brain after treatment for brain metastases.

Section 7.2.5: The typo at the end of the first sentence was corrected to "a temperature between 2-8ºC".
Consent, Appendix I: Under "During the Study", the blood tests for red and white blood cell levels will be conducted every week for 8 weeks instead of every other week.
Appendix II: Under "During Treatment", the blood tests for red and white blood cell levels will be conducted every week for 8 weeks instead of every other week.

SUMMARY OF CHANGES Amendment 1, Version Date: March 8, 2007
RTOG 0517, "Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast, and Prostate Cancer"

Study Chair: Michael J. Seider, PhD, MD; 330-375-3557; seiderm@summa-health.org

RTOG 0517 has been amended as follows:

Appendix I, sample consent, "Risks Related to Zoledronic Acid": At the recommendation of Novartis, maker of Zometa®, a paragraph was added (below the bulleted risks) concerning the risk of atrial fibrillation experienced by post-menopausal women with osteoporosis who received zoledronic acid in a recent study. In addition, the following changes were made:

Under "Likely", the risk of low calcium levels in the blood was added to be consistent with adverse events associated with zoledronic acid provided in Section 7.2.4.

Under "Less Likely", the following risks were added to be consistent with Section 7.2.4: weakness; increased sweating; redness of the skin and/or itching.

Under "Rare, but serious", the risks of "nerve damage" and "too much calcium in the blood" were deleted as incorrect. In addition, the risk of "swelling of the skin, the lining of the mouth and throat, and/or organs" was added to be consistent with Section 7.2.4.

Other Changes
Title page: The phrase, "Radiation Oncology Alliance", was added to the contact information for Dr. Wyatt, the Quality of Life Co-Chair.

Eligibility Checklist, Page 1: The subquestion below question 16 was amended for clarity.

Section 5.1 was updated to reflect current RTOG standard for study agent shipment. Corresponding changes were made in Section 7.2.7 and Appendix IV.

Section 7.2.2: The fifth sentence of the first paragraph was corrected to read, "The necessary infusion bags containing 100 mL calcium free 0.9% sodium chloride will be provided." In addition, the first sentence of the second paragraph was corrected to read, "A peripheral or central intravenous line…".

Section 11.3.3 and 11.3.4 were deleted as this text is no longer RTOG standard. The subsequent section was appropriately renumbered.

Appendix I, under "During the Study" and Appendix II, under "During Treatment": The CBC with differential and ANC will be done every other week instead of every week.

Appendix IV, "Opioid Analgesic Documentation", and Appendix V, "Brief Pain Inventory", were deleted, as this information is provided in the study case report forms. The subsequent appendix was appropriately renumbered. These appendices also were deleted from the Index page.