Results of a multi-institutional randomized phase II trial (RTOG 0915/NCCTG N0927) presented at the 2013 annual meeting of the American Society for Radiation Oncology (ASTRO) ATLANTA, Sept. 23, 2013 /PRNewswire/ -- Treating inoperable early-stage non-small cell lung cancer (NSCLC) with a single session of stereotactic body radiation therapy (SBRT) may be a viable option in some cases, according to the results of a multi-institutional randomized phase II trial led by the Radiation Therapy Oncology Group (RTOG) and reported yesterday in a presentation at the 2013 ASTRO Annual Meeting.
The presentation summarized results from the RTOG 0915 trial that compared two stereotactic body radiation therapy (SBRT) schedules for medically inoperable patients being treated for stage I peripheral non-small cell lung cancer. One group of patients received treatment spread out over four treatment sessions or "fractions" on consecutive days; the other group received treatment in a single fraction--a practice sometimes referred to as "lung radiosurgery." The median length of follow-up was 20.6 months for all patients.
"An earlier RTOG study demonstrated that a three-fraction approach can achieve good tumor control and overall survival rates for medically inoperable lung cancer patients," said Gregory M. M. Videtic, M.D., principal investigator on the RTOG study and radiation oncologist at The Cleveland Clinic in Ohio. "This study was designed to explore other schedules for delivering lung SBRT, and to evaluate toxicity rates at one year between the one-fraction and four-fraction patient groups. Secondarily, the study also assessed tumor control and overall survival rates when comparing one versus the multiple fraction approaches."
The study enrolled 94 patients who were treated at 30 institutions between September 2009 and March 2011. It compared the cumulative rates of grade 3 or higher toxicities at one year after treatment, including compromised respiratory function, neuropathy, injury to soft tissues or the chest wall, and skin reactions. Treatment plans were designed to maximize dose to the targeted lung tumor while keeping the dose to normal structures, such as the spinal cord, esophagus, health lung, heart, trachea, ribs, skin, and stomach, below specified normal tissue tolerances.
"We predetermined that if we found that the two groups had similar toxicity rates at one year and then saw that tumor control rates were comparable between them, then the shortest treatment schedule (i.e., one fraction) would be declared the 'winner,'" said Videtic. "At one year, the patients who received the single-fraction treatment met the pre-specified criteria that we had set with respect to adverse events and primary tumor control. We hope to use these findings to further define the optimal approach for treating inoperable early-stage lung cancer with SBRT."
Disclaimer The presentation summarized here was made by the principal investigator of RTOG 0915 and presented at a scientific meeting of the American Society for Radiation Oncology (ASTRO). Treatment outcomes described in this presentation are generally preliminary and are not intended to represent typical outcomes in a general patient population undergoing stereotactic body radiation therapy (SBRT) for lung cancer. Varian, as a medical device manufacturer, cannot and does not recommend any treatment technique or schedule. The study participants used diverse technologies that are cleared by the FDA for the delivery of SBRT. Varian Medical Systems manufactures such devices, however, the study did not require that patients receive treatment on any particular SBRT system. Varian, as a medical device manufacturer, cannot and does not recommend any treatment techniques or schedule.
Important Safety Information Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary or reproductive systems, fatigue, nausea, skin irritation, and hair loss. In some patients, they can be severe, and can include but are not limited to radiation induced liver disease (or radiation hepatitis), fractured ribs and persistent nausea. Treatment sessions may vary in complexity and time. Radiation treatment is not appropriate for all cancers. Cancer patients should discuss the potential for side effects and their severity as well as the benefits of radiation with their doctors to determine if radiation treatments are right for them.
About The Radiation Therapy Oncology Group (RTOG) The Radiation Therapy Oncology Group (RTOG) is administered by the American College of Radiology (ACR) and located in the ACR Clinical Research Center in Philadelphia, PA. RTOG is a multi-institutional international clinical cooperative group funded primarily by National Cancer Institute grants CA21661, CA32115 and CA37422. RTOG has 40 years of experience in conducting clinical trials and is comprised of over 300 major research institutions in the United States, Canada and internationally. The group is currently accruing to 40 studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient. RTOG is administered by the American College of Radiology (ACR), a national professional organization serving more than 32,000 radiologists, radiation oncologists, interventional radiologists and medical physicists with programs focusing on the practice of radiology and the delivery of comprehensive health care services. http://www.rtog.org
About Varian Medical Systems Varian Medical Systems, Inc. (NYSE: VAR), of Palo Alto, California, is the world's leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes, digital detectors, and image processing workstations for X-ray imaging in medical, scientific, and industrial applications and also supplies high-energy X-ray devices for cargo screening and non-destructive testing applications. Varian Medical Systems employs approximately 6,350 people who are located at manufacturing sites in North America, Europe, and China and approximately 70 sales and support offices around the world. For more information, visit http://www.varian.com or follow us on Twitter.
 Timmerman et al. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010; 303:1070-1076.
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