North Shore-LIJ Health System seeks oropharynx patients for phase I clinical trial

Jul 26 2010

The North Shore-LIJ Health System Department of Radiation Medicine announced today it is seeking patients with cancer of the oropharynx (back of the mouth) to participate in a Phase I clinical trial.

Subjects must be newly diagnosed and not have undergone any previous treatment. Further, their cancer must be unassociated with the human papilloma virus (HPV-negative), or, if it is HPV-positive, they must be current or former pack-a-day smokers for at least 10 years.

Patients with HPV-negative oropharyngeal cancer are not cured as frequently by standard radiation therapy (IMRT) as are patients with the HPV-positive type, according to David Schwartz, MD, vice chair of radiation medicine at the North Shore-LIJ Health System and the study's principal investigator. The hypothesis of the study is that standard radiation therapy followed by a "boost" of image-guided stereotactic radiosurgery (SRS) will achieve a better cure rate for these two groups of patients.

Patients who volunteer to participate in the study are first screened to determine whether they are eligible, after which they provide their informed consent. Treatment can then begin--six weeks of standard radiation, possibly in combination with chemotherapy, depending on the stage of the cancer. Research nurse Sara Parise, RN, BSN, coordinates the patients' treatment.

And now on to the "boost" of SRS, which is what the study is all about. A Phase I trial establishes the safety of a treatment, and so the first group of patients receives a moderate dose of SRS, only 8Gy (Gy stands for gray, a unit of energy absorbed from ionizing radiation). This is a rigorous treatment, comparable to standard doses. All Phase I trials begin with a dose of the experimental treatment that is believed to be safe, followed by very careful monitoring of the patients' reactions. If the dose of 8Gy6 is well tolerated, the next group of patients will get a dose 2Gy higher, and again the side effects will be carefully monitored. The maximum dose will be 18Gy.

"This trial is one of the very first attempts to increase cure rates for the large number of patients with HPV-unassociated oropharyngeal cancer," Dr. Schwartz stated. "SRS is a safe, highly sophisticated technique that has generated much interest for its ability to overcome resistance of tumors to radiation. We are pleased that the North Shore-LIJ Health System has the technology and the expertise to offer this trial before any other center in the metropolitan area or anywhere in the country. Our hope is that it serves as a stepping stone for expanded use of SRS as part of standard treatment for people who face this illness."