This two-part application proposes to continue support for clinical trials research in particle radiation therapy. The first part, recognizing worldwide interest in proton therapy, calls for establishing a multi-center clinical trials group to be designated the Proton Radiation Oncology Group (PROG). The PROG will advance the knowledge of radiation therapy with protons begun by the Proton Therapy Cooperative Oncology Group, which has been a forum for developing the physics and engineering aspects of proton therapy, and sharing the results of individual institution studies. The PROG will initially include three U.S. facilities and will develop protocols to determine whether the clinical application of proton beams is superior to the best current photon/electron treatment methods for patients with tumors at select anatomical sites. Foreign investigators from proton facilities in the Soviet Union, Japan, Sweden, Switzerland, United Kingdom, France and Republic of South Africa will be encouraged to participate in the PROG research efforts enhancing the level of proton therapy research through improved communications and increased accrual over shortened time periods. The National Cancer Institute has committed considerable resources for the execution of clinical trials for fast neutron therapy. The second part of this application provides for the continued collection of data on patients treated with fast neutrons and to complete analyses and publication of results from eight studies including three large phase III trials in head and neck, prostate and lung cancer. This data and the subsequent analyses will complete this research effort by developing definitive reports for the existing protocols and disease sites.
