Intraoperative radiotherapy (IORT), usually combined with chemotherapy, surgery and external irradiation, has been proven effective in controlling a number of aggressive, primary, non-metastatic malignant tumors. A number of centers with IORT treatment capability plan to conduct clinical trials under the auspices of the International Society of Intraoperative Radiation Therapy (ISIORT).

New treatments or combinations of treatments are scientifically tested in Clinical Treatment Trials that involve the participation of consenting patients:

Phase I trials provide guidance as to how a new treatment should be given, how often it should be given and what dose is safe.

Phase II trials continue to test the safety of the new treatment while beginning to evaluate its effectiveness.

Phase III trials, often enrolling many patients at different medical centers, evaluate a new treatment or combination of treatments in comparison to the current standard treatment. Participants are randomly assigned to either the standard treatment group or the new treatment group.

The following are sponsored Clinical Treatment Trials currently in the implementation and planning stage by the ISIORT that include IORT in the treatment protocol:

Protocol ISIORT-01
Phase III study for locally Advanced Primary and Recurrent Colorectal Cancer

Protocol ISIORT-02
Phase II Study for Retroperitoneal Sarcomas

Proposed:
Phase II study for Stage III Non-Small cell Lung Cancer

Proposed:
Phase III study for early Stage breast Cancer

Proposed:
Phase III study for unresectable or borderline resectable Pancreatic Cancer

For details concerning any of the IORT protocols, please contact a participating IORT treatment center.