For all members and friends of the Southwest Oncology Group, the SWOG Update will keep you informed of what's happening with the Group. News to report? Send it to communications@swog.org.
How should we spell success?
Questions of how we define success in cancer research and how costs should factor into that definition have been much in the news.
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S0702: Zoledronic acid and ONJ risk
Patients taking zoledronic acid seem to face an increased risk of osteonecrosis of the jaw, or ONJ. S0702 seeks answers.
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S0715: Does ALC prevent neuropathy?
Pain and numbness in hands and feet is a common side effect of taxane-based chemotherapy. Can the dietary supplement acetyl-L-carnitine prevent it?
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The War on Cancer: Raise the bar, or move the goal line?
Plenary Session SWOG Fall 2009 Group Meeting
Friday, October 23, 12:15 - 2:45 pm
Gold Level, Regency B - D
Hyatt Regency Chicago
S0702: Observational study of osteonecrosis of the jaw (ONJ) in patients with metastatic bone disease starting zoledronic acid
Patients whose cancer has spread to their bones often use bisphosphonates to reduce their risk of fracture. Some studies have shown that such patients have an increased risk of ONJ, in which areas of jawbone die.
ONJ can cause swelling of the jaw's soft tissues, pain, infection, loosening of the teeth, drainage, and exposed jawbone. It generally occurs after a tooth extraction or some other trauma to the jaw, and treatment is difficult and often unsuccessful.
Catherine Van Poznak, M.D., study coordinator of S0702
(Photo: UMHS)
SWOG study S0702 will measure this ONJ risk among patients with cancer getting the bisphosphonate drug most widely used in cancer treatment in the U.S. -- zoledronic acid, also known by the brand name Zometa.
"The overall risk of ONJ in patients with bone metastases treated with intravenous bisphosphonates appears to range between one and ten percent," says study coordinator Catherine Van Poznak, M.D., of the University of Michigan Medical School.
"S0702 will refine our understanding of the incidence, risk factors, clinical presentation, and natural history of ONJ in patients starting zoledronic acid treatment."
To do so, S0702 will recruit 7,000 patients who will be followed for three years, with dental and medical checkups every six months. Those who do develop ONJ will be examined every three months. S0702 is an observational study and does not dictate care of the study participants.
Patients with bone metastases of myeloma, solid tumor, or other malignancies who are just starting treatment with zoledronic acid may be eligible.
Those with a prior history of ONJ or who have had radiation therapy to the jaw are not eligible. Please review the detailed eligibility requirements .
Eligible patients can find the nearest participating institution online or by contacting the Southwest Oncology Group at (210) 614-8808 or at protocols@swog.org.
Sites are paid $1,250 per initial patient enrollment and $125 twice-yearly with submission of follow-up forms. Each form confirming a case of ONJ brings a site an additional $1,250 plus $250 for quarterly follow-up forms.
Additional funding is available to assist in covering the cost of the dental exams and care for uninsured or underinsured participants.
The SWOG Clinical Trials Initiative (SWOG-CTI) supports this study.
Questions of how we define success in cancer research and how costs should factor into that definition have been much in the news.
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