New unit of Electro-Hyperthermia modulated (mEHT / Oncothermia) in the University Hospital Marqués de Valdecilla

The Marqués de Valdecilla University Hospital is one of the most prominent public hospitals in Spain. Very soon it will have the first Electro-Hyperthermia modulated equipment (mEHT / Oncothermia) located in a public hospital in Spain.

The medical center works in collaboration with the Center for Medical Simulation de Boston.

This Radiation Oncology unit has designed a clinical study that will be carried out with cancer patients in Phase III, combining Oncothermia with standard chemotherapy and radiotherapy.

The corresponding clinical study proposal is transcribed bellow:

Future position of oncothermia combination with standard chemo and radiotherapy in clinical practice – Highlights of upcoming Phase III clinical studies in Hospital Universitario Marqués de Valdecilla (HUMV)

Elisabeth E. Arrojo

Ratiation Oncologist

University Hospital Marqués de Valdecilla, Santander, Spain.

Introdution

Aggressive malignant tumors are known to be usually hypoxic. It´s well known that hypoxia decreases tumors’ response to radiotherapy (radiosensitivity). At least 2 or 3 times more radiation dose is needed to kill hypoxic cells compared with well oxygenated cells.

Several studies have shown that modulated electro hyperthermia (mEHT) is able to increase tumor oxygenation, and thus alleviate the hypoxia that would lead to greater radioresistance, establishing itself as an optical moment to apply radiotherapy, about 30 minutes after the treatment of mEHT.

There are also several studies showing the efficacy of mEHT in killing cancer cells when used alone without any other cancer treatments.

These are some of the reasons why the combination of these treatments (mEHT + Radiochemotherapy) could result on an improvement in tumor control and survival for cancer patients. Despite several studies about mEHT treatment in cancer patients alone or combined with standard radio-chemotherapy have been published with wonderful results, we still do
not have enough phase III trials to clarify the role of mEHT on cancer treatment.

Purpose

To perform three different phase III clinical studies to test whether the combination of radiochemotherapy treatment with mEHT in the 30 minutes prior to the radiotherapy session, or the treatment in monotherapy with mEHT in those cases not susceptible to another oncological treatment, will improve local control (primary objective) and/or survival (secondary objective) in patients with high-grade brain tumors, pancreatic cancer or rectal cancer, without increasing side effects from the standard treatments.

Material and methods

Patients diagnosed with high grade glioma, pancreatic cancer, or rectal cancer will be included in three different phase III clinical studies. These studies will include newly diagnosed cancer patients or patients with recurrent malignant tumors after treatment with standard therapies. The study for patients diagnosed with high grade brain glioma (stages III and IV) will include patients who will receive treatment in an adjuvant setting after surgery combining mEHT with standard chemo-radiotherapy or with mEHT as the only treatment in those cases not candidates to surgery, chemo and/or radiotherapy. The clinical study about pancreatic cancer, will include patients with locally advanced cancer and again, mEHT treatment will be combined with the standard chemo-radiotherapy treatment in a neoadjuvant, radical, palliative or adjuvant setting, or will be the unique treatment in those cases not amenable to be treated with standard therapies. The third study, is for patients diagnosed with rectal cancer who meet the criteria to receive standard treatment with neoadjuvant chemo and radiotherapy, in whom mEHT will be combined with these neoadjuvant treatments. In all the studies, when mEHT is combined with radiotherapy, it will be always delivered around 30 minutes before each radiotherapy session. Patients with history of other cancer in the past 10 years will be excluded.

Results

Three different phase III clinical studies have been already designed to be performed at the radiation oncology department of Valdecilla University Hospital in Santander, Spain. We have already received the approval of the University Hospital Marqués de Valdecilla and the “Idival” research institute, which will be also a collaborator, to begin with the studies, and we also have the necessary insurances to run them. We have also appointed a coordinator to control and check the proper development of these studies.

Conclusion

Modulated electro hyperthermia combined with standard radio and chemotherapy or as a unique treatment in cancer patients not candidate to standard treatment, looks very promising to improve local control and survival in cancer patients. These clinical studies will give us very valuable information about the role of mEHT in cancer treatment, and its contribution as a radiotherapy and chemotherapy sensitizer.

More information:

Arrojo E. (2018): Future position of oncothermia combination with standard chemo and radiotherapy in clinical practice – Highlights of upcoming Phase III clinical studies in Hospital Universitario Marqués de Valdecilla (HUMV); Oncothermia Journal 24:59-90 www.oncothermia-journal.com/journal/2018/Future_position_of_oncothermia .pdf