BSD Medical Corporation (NASDAQ: BSDM) reports initiation of a Phase I/II clinical study (HyRec-Trial) using the BSD-2000 Hyperthermia System (BSD-2000) to deliver hyperthermia in combination with chemotherapy (5-FU/oxaliplatin) and radiotherapy for the treatment of patients with locally recurrent rectal cancer. The multicenter study, which will be sponsored by the University of Erlangen Medical School (Erlangen), will evaluate the feasibility and the efficacy of adding hyperthermia to a multimodal treatment regimen that includes potent new chemotherapeutic agents such as oxaliplatin. The study will initially enroll 59 patients. If the study parameters are met, a randomized Phase III clinical trial will be initiated. The HyRec-Trial has been approved by the German Cancer Society.
The coordinating investigator for the study is Oliver Ott, MD, Associate Professor, Department of Radiation Oncology, Erlangen. Erlangen was instrumental in establishing preoperative chemotherapy and radiation as the current standard of care for treating stage II and III rectal cancer and the treatment recommended by the National Comprehensive Cancer Network (NCCN) Rectal Cancer Treatment Guidelines (2.2013). The NCCN Clinical Practice Guidelines in Oncology are the recognized standards for clinical treatment policy in the oncology community. Rolf Sauer, MD, who is Professor Emeritus at Erlangen, led the seminal German clinical studies, which were published in 2004 and 2012, that resulted in establishing the standard of care for stage II and III rectal cancer. Dr. Sauer is also the initiator and coordinator of the Erlangen based Atzelsberg Circle for hyperthermia, which was established in 2007 to establish the benefit of hyperthermia through definitive clinical studies. Dr. Sauer is a leading expert in the treatment of cancer, serves as the editor of the longest running scientific publication in radiation oncology, Strahlentherapie & Onkologie, and has been awarded the Order of Merit of the German Republic as well as the German Cancer Award. He is also an honorary member of the Radiological Society of North America.
Two randomized studies have demonstrated that radiotherapy combined with chemotherapy and deep hyperthermia can improve response, local control and survival rates in certain patients with rectal cancer. Berdov et al. ("Thermoradiotherapy of patients with locally advanced carcinoma of the rectum." Int J Hyperthermia. 1990) reported on 115 patients with rectal cancer who received radiotherapy alone (n=59) and radiotherapy combined with hyperthermia (n=56). Complete and partial remission rates (16% vs. 2% and 54% vs. 34%; P<0.05) as well as overall survival rates at five years (36% vs. 7%; P<0.05) were significantly improved in the hyperthermia group. Rau et al. ("Stellenwert der Hyperthermie für die chirurgische Onkologie." Viszeralchirurgie 2002) reported on a randomized trial with 137 patients with rectal cancer who were treated with neoadjuvant radiochemotherapy combined with (n=69) or without (n=68) hyperthermia. Response (complete and partial remission rates) was significantly better for the hyperthermia group (66% vs. 49%; P<0.05). Time to progression at three years was also better for the hyperthermia group (66% vs. 49%; P<0.05).