Hyperthermia and ablation system developer BSD Medical has reported the launch of a clinical trial in Germany to evaluate the feasibility and efficacy of adding hyperthermia to a chemoradiotherapy regime to treat patients with locally recurrent rectal cancer.
The HyRec-Trial, a multicenter study sponsored by the University of Erlangen Medical School and approved by the German Cancer Society, intends to enroll 59 patients. They will receive a combination of chemotherapy (5-FU/oxaliplatin), radiotherapy, and hyperthermia treatments using the BSD-2000 hyperthermia system.
Dr. Oliver Ott, associate professor of the department of radiation oncology, is the principal investigator of this phase I/II clinical study. The Universitätsklinikum Erlangen has been instrumental in establishing preoperative chemotherapy and radiation as the current standard of care for treating stage II and III rectal cancer. Other participating institutions include the Universitätsklinikum Munich Grosshadern and UMS Tübingen.
A randomized phase III clinical trial will be initiated if the study parameters are met. To date, published results of two randomized clinical trials have demonstrated that radiotherapy combined with chemotherapy and deep hyperthermia treatment can improve tumor response, local control, and survival rates in some patients with rectal cancer, according to BSD.
