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September 6, 2001 Paul C. Martin, Ph.D. S. James Adelstein, M.D., Ph.D. Dear Paul and Jim, At our last meeting concerning the proton therapy program, and in your thoughtful response to our conversation, you requested that I provide more detail of the plan to transition the HCL proton therapy program to the Northeast Proton Therapy (NPTC). This communication is a response to that request. The MGH currently treats (has the capacity to treat – the number varies) 22 patients per day at the HCL: 18 large-field patients, 4 ocular melanoma patients. These treatments occur 4 days a week. On Tuesdays, when other patients are not treated, we treat 3 radiosurgery patients (except for scheduled HCL preventative maintenance days). The number of fractions (treatments) for each type of patient is approximately 25 (average) for largefield patients, 5 for ocular melanoma patients and 1 for radiosurgery patients. We begin treatments about 8:00 AM and finish about 8:30 PM each day except for Tuesdays when we treat radiosurgery patients from 10:00 AM until 3:30 PM. The attached graph gives the details of the transition plan. The number of patients in each category (LF = large-field, Eyes = ocular melanoma, and RS = radiosurgery) represent monthly averages – the actual number at any given time may vary. We plan to begin treatments at the NPTC the first week of November 2001 on Gantry #1. We will start an average of 3 new large-field patients per month at the NPTC in the disease categories currently treated at the HCL (pending final NCI approval). Therefore, the large-field census at the HCL will drop at the rate of 3 per month. We will start no new large field patients at the HCL after March 1, 2002. Beginning in December 2001, we must also begin treating patients in our NCI-funded research program and will start these patients at the rate of about two per month. We will begin with a new prostate cancer protocol and then open the retinoblastoma protocol in March 2002. We will cease treatment of ocular melanoma patients about February 1, 2002 and (after one month during which we will move the equipment to the NPTC, install it there and carry out clinical commissioning) begin eye treatments in the NPTC eye treatment room about March 1. The radiosurgery patients will be treated at the HCL until April 1, 2002, then transferred to the NPTC – no time lag is required for transfer of these patients because we will treat them on one of the gantries rather than use the STAR device that is used at the HCL. Our present plans are to initially commission Gantry #2 for the treatment of patients that require small treatment fields such as radiosurgery and retinoblastoma patients. In March and the therapists remaining at the HCL will treat three large field patients then go to the NPTC to treat ocular melanoma patients in the eye treatment room plus retinoblastoma patients on Gantry #2. Beginning in April, they would also be treating radiosurgery patients on Gantry #2. By the end of April we hope to have ceased treatments at the HCL and all clinical staff will be working full time at the NPTC. You inquired about staffing and asked if additional staffing would speed up the transition process. We are already staffed with therapists to treat two shifts per day at the HCL and we are hiring additional therapy staff. We will increase our dosimetry staff in early 2002. Beginning in November we will have two therapists at the NPTC for one-half day and then increase this to a full day by January 2002. By the end of January 2002 we will be treating full single-shift schedules at both the NPTC and the HCL – we will be treating 13 patients/day at the HCL (9 large-field and 4 eyes), plus radiosurgery patients on Tuesdays, and 13 large-field patients/day at the NPTC. By this time we will have added additional staff at the NPTC and will be treating extended hours. This predicted load at the NPTC may seem to be large at such an early stage however, at that time, 4 of the patients will be prostate patients whose treatments are relatively simple compared to the complexity of the usual treatments at the HCL. At this time we think that we will have treatment times reduced to one hour for the complex cases and 45 minutes for prostate patients, therefore we should be treating 12 hours/day at the NPTC by the end of January. We expect that our efficiency will quickly improve to the point that we can take 15 minutes off both types of treatments by March. This schedule is certainly ambitious but doable. We are encouraged by the fact we have a highly trained, competent and dedicated staff that has many years of experience at the HCL. Should unforeseen difficulties arise, we also have the option of giving certain patients, particularly those having paranasal sinus and nasopharynx cancers, highly advanced treatments using x-ray intensity modulation. These treatments are comparable to standard proton treatments but will not compete with more advanced proton techniques using pencil beam scanning. We will introduce these treatments at the NPTC in about two years. You stated that our colleagues in Cambridge have a less optimistic view of our schedule than the MGH holds. This is interesting in light of the fact that none of the Harvard staff are fully knowledgeable of our schedule because it has fully evolved only very recently. This is because we have not, until the past few weeks, been aware that the NCI may count treatment of the current HCL case load at the NPTC toward funding our clinical research grant, and that Harvard University may be willing to extend our stay at the Harvard Cyclotron past November 31, 2001. It may be useful for you to talk to Al Smith, who has been in charge of the proton clinical operations for about 10 years and is responsible for the transition of clinical operations from the HCL to the NPTC. He is the person, among both my staff and the HCL staff, who has the broadest and most in-depth view of these issues. We have some additional uncertainty in the NPTC operations due to the construction of a new ambulatory care facility adjacent to the NPTC. The construction crews will be adding additional shielding to the outside walls of the NPTC and, at times, will remove, then replace, some of the soil adjacent to the NPTC in order to do their foundation work. These activities will not halt our operations but we may have to operate at less than full capacity for some periods in order to comply with state regulations regarding radiation protection of the construction workers. For this reason, and because it is important to have contingency in the schedule, we request that the HCL be available for patient treatments until May 30, 2002. An additional function that we have not previously discussed is the “outside user” program at the HCL. This is an important program but one which we would want the HCL to continue as long as possible. We intend to accommodate this work at the NPTC in an experimental room designed for that propose, however it does not seem prudent to start up an outside user program until the clinical treatments have been fully transferred and we have stable and routine clinical operation. Please keep in mind that the transition plan presented here has been developed in the last few days and it may be modified as it undergoes additional internal review and discussion. Also, we have only received oral agreement from the NCI concerning our petition to have the HCL caseload count towards satisfying their requirements to fund our clinical grant – we will feel more confident when a written agreement is in our hands. We will inform you should any substantial changes in this plan become necessary. On a final note, both the equipment and the software are working well at the NPTC. The clinical users report that they are pleased with the recent improvements in reliability and functionality. By late September we should be in full-scale clinical commissioning mode. Again, we apologize for the many and prolonged delays in getting the NPTC to this final stage. This has been at great cost to the MGH and has caused delays in the Harvard University construction plans. We will do everything we can to bring the remainder of the program to a timely conclusion. I am grateful for your support and interest in the welfare of our cancer patients. Your positive response to our request for extended access to the HCL will ensure that patient welfare is not compromised by our delays. Sincerely, Jay S. Loeffler, M.D. Chair, Department of Radiation Oncology Cc: James M. Mongon, M.D. President, Massachusetts General Hospital