TARGIT Procedure May Eliminate 6 Weeks of Radiation TherapyHAMPTON, Virginia – July28, 2008– Questions were racing through Vela Cross’ mind when she was diagnosed with invasive breast cancer in May. Would she have just the tumor removed or her entire breast? Would she have chemotherapy? How about radiation?
Because doctors at Sentara CarePlex Hospital were involved in the TARGIT Trial, Cross agreed to become the first East Coast patient to receive an experimental procedure for her cancer.
Sentara CarePlex Hospital is participating in an international clinical trial open to early stage breast cancer patients comparing conventional external radiation with an investigational single-dose radiation treatment. The TARGIT Trial, which stands for TARGeted Intraoperative-radiation Therapy, is a randomized study that could help determine if the single-dose is effective.
“Regular radiation would have really interrupted my life,” says Cross. “This was, to me, a simple operation compared to what some of my friends with breast cancer have been through,” she said.
“It’s hard to believe that some women elect to have their breasts removed because scheduling dozens of radiation treatments over 6 weeks seems too disruptive to their lives.” says surgical oncologist Dr. Richard Hoefer, medical director of Sentara CarePlex Hospital Cancer Services. “We hope our participation in this research study offers women information that will change their options,” he continues.
Sentara CarePlex Hospital is among only five leading centers in the U.S. and the only East Coast hospital enrolling patients in this new international research study offered at 22 locations world wide. The purpose of the research study is to evaluate the effectiveness of a single dose of radiation given during surgery to remove breast cancer compared to the standard treatment of 6-8 weeks of radiation therapy.
In this randomized trial, half of the trial participants will get an investigational one-time dose of radiation while still under anesthesia following the removal of a cancerous tumor. The One-Step Procedure involves participants being given radiation treatment while still under anesthetic in the operating room, and the treatment will be completed at the time of surgery. The Two-Step Procedure involves having surgery, then returning at a later date to have the Targeted Intra-operative Radiation Treatment. A ball-shaped applicator is placed in the tumor cavity of eligible participants for a one-time dose of radiation, literally targeted to the breast cells with the highest risk of cancer recurrence—those that were directly surrounded the tumor. The other trial participants receive the standard 6-8 weeks of external radiation therapy, a method proven to be effective in the last two decades for helping kill potential cancer cells that may have been left behind in the breast.
Previous trials in Europe involving this treatment known as Intra-operative radiation therapy (IORT) have shown promise. The system that delivers the single-dose radiation was cleared by the U.S. Food and Drug Administration (FDA) as safe and effective, and trials at Sentara facilities are subject to a rigorous approval process.
“This study has the potential to significantly change the way we care for early-stage breast cancer patients,” says radiation oncologist Dr. Michael Miller,a co-investigator on the study, a physician with Virginia Oncology Associates and medical director of Sentara CarePlex Hospital’s radiation oncology department. “The early results of previous IntraBeam® studies are encouraging,” he continued.
“I really wanted to help other women and future generations,” says Cross, who became the first East Coast patient to have the single-dose option in the study. “If it works for me, it may work for other women too,” she said.
To learn more about the TARGIT Trial or the Sentara Cancer Network, please call 757-549-1939 or visit our website at www.sentara.com/cancer.
About TARGIT Trial. TARGIT is a phase III international research study, enrolling post menopausal women at least 45 years old with single site invasive breast cancer measuring less than 3 centimeters (1 1/8 inches) or less. To be considered for the trial, patients must have operable breast cancer in only one location. Currently, about 1,100 patients worldwide are enrolled in the study aiming for a total of 2,400 participants. For a patient to receive IntraBeam® Single-Treatment Radiation, they must enroll in the TARGIT Trial. Participants will have an equal chance of being placed in either the single-dose group or the standard 6-8 week therapy group. Some of the considerations include age, type of cancer, tumor size, and lymph node involvement.