The objectives of Project 1 are to conduct clinical trials designed to investigate the clinical advantages of proton beams in disease sites where the anticipated increase in target dose, over that given by conventional x-ray and electron therapy, is expected to result in a significant increase in the therapeutic gain. The improved dose distributions of proton beams provide dose localization which our treatment planning studies show to have dose-volume histograms for tumors and normal tissues which are superior to those for the equivalent arrangement of x-ray beams. Moreover, and most importantly, our clinical studies in skull base and cervical spine chordomas and chondrosarcoma and in uveal melanomas, show a significant increase in local control using protons when compared to historical results with conventional treatments. Our experimental plan is to employ Phase I/Il and Ill clinical trials to determine the clinical gains achieved by proton dose distributions. The resultant data will constitute valuable information on two fundamental problems in radiation therapy: 1) the slopes of dose response curves for tumor control and normal tissue damage; and 2) the dependence of tolerance on the volume of normal tissue irradiated. The proposed clinical trials schema has two phases: the first phase is a continuation of our current clinical trials at the Harvard Cyclotron Laboratory (HCL) and the initiation of new studies there which are possible with the limited energy (160 MeV) fixed beams of the HCL: and the second phase is the transfer of the HCL clinical studies to the Northeast Proton Therapy Center (NPTC), in mid 1998, and the initiation of new clinical trials at the NPTC made possible by the higher energies (up to 235 MeV), isocentric gantries, and modem treatment systems of the NPTC. Clinical Trials at the HCL: We will continue the ongoing studies of: chordoma/chondrosarcoma of skull base and cervical spine; uveal melanoma; benign meningioma; paranasal sinus tumors; and malignant gliomas. We will initiate a Phase III study of the efficacy of Alpha Interferon in the prevention of Rubeosis Iridis, and Phase I/Il studies in acoustic neuromas; ocular adnexae and orbital tumors; nasopharynx cancers; malignant meningioma; and sarcomas of the sacrum; retinoblastoma; and reirradiation of recurrent pituitary adenomas. Clinical Trials at the NPTC: We will consider Phase III trials for the rectum/recto-sigmoid; soft tissues of the retroperitioneum; uterine cervix; prostate; and non small cell lung cancer; and Phase I/Il studies for urinary bladder, biliary duct, hepatic malignancies and pediatric tumors.
Showing the most recent 10 out of 260 publications
