Clinical Proton Radiation Therapy Research at the Francis H. Burr Proton Therapy Center

2007 ◽  
Vol 6 (4_suppl) ◽  
pp. 61-66 ◽  
Author(s):  
Thomas F. DeLaney
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
Clinical Research ◽  
Local Control ◽  
Proton Therapy ◽  
Dose Escalation ◽  
Normal Tissue ◽  
Late Toxicity ◽  
Proton Radiation ◽  
Therapy Center

The Francis H. Burr Proton Therapy Center has a 230 MeV cyclotron from which proton beams are directed to two isocentric gantries, a stereotactic intracranial beam line, and an eye line. Because of improved physical dose distribution, proton radiotherapy allows dose escalation to improve local tumor control in anatomic sites and histologies where local control is suboptimal with photons. The improved dose localization also reduces normal-tissue doses with an anticipated reduction in acute and late toxicity. Clinical treatment protocols, developed to exploit the dosimetric advantages of protons over photons, have been grouped into two broad categories. In the first, dose is escalated for anatomic sites where local control with conventional radiation doses has been suboptimal. In the second, normal-tissue sparing with protons is designed to minimize acute and late toxicity. Treatment of patients on clinical research protocols has been encouraged. Patient treatments began on the first gantry in November 2001; on the eye line in April 2002; on the second gantry in May 2002; and on the stereotactic intracranial line in August 2006. The facility currently treats 60 patients per day, including up to six children daily under anesthesia. Dose-escalation studies have been completed for early stage prostate cancer (in conjunction with Loma Linda University) and sarcomas of the cervical spine/base of skull and thoracolumbosacral spine. Protocols are in progress or development for carcinoma of the nasopharynx, paranasal sinus carcinoma, non-small-cell lung carcinoma, locally advanced carcinoma of the prostate, hepatocellular carcinoma, and pancreatic cancer. Studies evaluating the use of protons for morbidity reduction include protocols for craniospinal irradiation in conjunction with systemic chemotherapy for medulloblastoma, retinoblastoma, pediatric rhabdomyosarcoma, other pediatric sarcomas, and accelerated, hypofractionated partial breast irradiation for T1N0 breast carcinomas. For pediatric patients, protons have also been accepted as an alternative to photons for children enrolled in Children's Oncology Group (COG) protocols. Treatment of patients on these studies has often required the development of new treatment techniques ( i.e., matching abutting fields for craniospinal irradiation), respiratory gating, and development of appropriate clinical infrastructure support ( i.e., increase in availability of pediatric anesthesia) to allow appropriate treatment. In addition, a clinical research infrastructure for protocol development and data management is required. Results to date indicate that proton radiation therapy offers several potential treatment advantages to patients that can be studied in the setting of clinical trials. Patients' willingness to enter these clinical trials seems to be quite high; accrual to selected studies has been favorable.

High linear energy transfer (LET) radiation therapy in recurrent, metastatic, or unresectable rectal adenocarcinoma.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 612-612
Author(s):  
P. Paximadis ◽  
D. Elliott ◽  
A. F. Shields ◽  
P. A. Philip ◽  
D. W. Weaver ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Local Control ◽  
Normal Tissue ◽  
Rectal Adenocarcinoma ◽  
Late Toxicity ◽  
Neutron Radiation ◽  
Neutron Dose ◽  
Mixed Beam ◽  
Photon Dose ◽  
High Let

612 Background: The purpose of this study was to retrospectively analyze the outcomes of patients with recurrent, metastatic, or unresectable rectal adenocarcinoma treated with mixed beam photon and high LET radiotherapy. Methods: Between 1995 and 2005, the high LET database was queried to identify patients with rectal adenocarcinoma. Local control and overall survival (OS) were calculated using the Kaplan-Meier method. Acute and chronic toxicities were graded using the common terminology criteria for adverse events (CTCAE) v4.0 grading system. Biological equivalent dose (BED) was calculated for tumor and normal tissue of both the photon dose and neutron dose for 10 patients. Results: 11 patients with recurrent, metastatic, or unresectable rectal adenocarcinoma were identified as being treated with mixed photon-neutron radiation. The median age of patients in the study was 58 (range: 38-79). There were 8 male patients and 3 female patients. Median follow-up was 6 months (range: 4-76 months). Patients received a median photon dose of 40Gy (range: 26-50.4Gy) and a median neutron dose of 8nGy (range: 6-10nGy). Seven patients received radiation given concurrently with 5-FU. The median OS was 16 months (range: 4-76 months), with 1 and 2-year OS of 56% and 22%, respectively. Local control was achieved in 9 of 11 (82%) patients. Local progression occurring in two patients occurred at 5 months after completion of RT. The median tumor BED in patients achieving local control was 72.5 Gy (range: 57.1-83.5 Gy). There was a nonsignificant difference in median normal tissue BED of patients with grade 3-4 late toxicity of 104.8 Gy (range: 81.1-115.1 Gy), compared with 95.3Gy (range: 89.0-104.6 Gy) for those patients with grade 1-2 late toxicity. Conclusions: Our experience demonstrates that treatment of unresectable rectal tumors with mixed photon-neutron achieved excellent local control. With the added capabilities of intensity modulated neutron radiation therapy (IMNRT), the incidence of treatment-related morbidity may be improved while taking advantage of the superior tumor control that high-LET radiation can impart. No significant financial relationships to disclose.

The Main Directions of Clinical Application of Modern Proton Therapy

2019 ◽  
pp. 41-51
Author(s):  
А. Самойлов ◽  
A. Samoylov ◽  
Ж. Смирнова ◽  
Zh. Smirnova ◽  
В. Климанов ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Clinical Application ◽  
Proton Therapy ◽  
Clinical Studies ◽  
Photon Radiation ◽  
Proton Radiation ◽  
Proton Radiation Therapy ◽  
Current State ◽  
The Cost

This paper analyzes the current state of clinical application of proton radiation therapy (PRT) for the treatment of cancer. In particular, the indications for the use of PRT for the treatment of specific pathologies, the results and condition of randomized clinical studies of PRT compared to photon radiation therapy (PhRT) are considered, the cost of PRT is compared with the cost of PhRT. The focus is on discussing the results of PRT using in advanced countriesand Russia for the treatment of several common tumor sites. In the conclusion of the work, the ways of further improvement of radiobiology, dose delivering technology and dosimetric support of PRT are considered.

Factors affecting the offering and enrollment of patients on clinical trials in radiation oncology.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17571-e17571
Author(s):  
Shayna Eliana Rich ◽  
Nancy Price Mendenhall
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
General Population ◽  
Proton Therapy ◽  
New Technologies ◽  
Patient Acceptance ◽  
Proton Radiation ◽  
Available N ◽  
Treatment Approaches ◽  
Factors Affecting

e17571 Background: Improvements in cancer treatment require significant patient involvement in research, which may be particularly limited for new technologies such as proton radiation therapy. Studies with biased referrals or enrollment may not be generalizable to a general population. This study examines the reasons why patients were not offered or refused enrollment in clinical trials at the University of Florida Proton Therapy Institute (UFPTI). Methods: All patients seen at UFPTI between April-October 2012 for proton therapy for tumor sites with a clinical trial available (N=463) had information collected prospectively regarding whether they were offered enrollment and consented for clinical trials, and the reasons for each decision. The majority of patients had already secured funding for proton therapy. Results: Seven percent (34/463) of patients were ineligible for an available clinical trial, due to study exclusion criteria, concerns for patient safety based on comorbidity, or concerns for data integrity (e.g., other non-skin cancer within five years). Only 3% (9/275) of eligible patients were not offered a clinical trial. Forty-four percent (99/226) of patients offered a clinical trial refused. The most common reasons for refusal included: discomfort with lack of mature data, dislike of protocol, fear that protocol is not best option for disease control, and fear of side effects. Although UFPTI treats a variety of malignancies, the overwhelming majority of those who refused consent were prostate adenocarcinoma patients, who often self-referred for proton therapy. Conclusions: Despite near universal availability of clinical trials at UFPTI, less than half of patients enroll in clinical trials. The greatest factor for non-enrollment appears to be patient acceptance. Despite the availability of non-randomized trials with fairly standard treatment approaches, 44% refused to enroll on clinical trials, suggesting discomfort for less well documented treatment approaches. Further studies should examine whether findings are similar among all US cancer patients, as patients seeking proton therapy may not resemble the general population.

Prospective phase 1 study assessing feasibility of IMRT and IGART to deliver simultaneous integrated high-dose tumor boost (up to 70 Gy) for the radical treatment of localized muscle-invasive bladder cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 307-307
Author(s):  
Shaista Hafeez ◽  
Karole Warren-Oseni ◽  
Helen McNair ◽  
Vibeke Hansen ◽  
Fiona McDonald ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Dose Escalation ◽  
Normal Tissue ◽  
Cone Beam Ct ◽  
Phase 1 ◽  
Randomised Trial ◽  
Late Toxicity ◽  
High Dose ◽  
Normal Bladder ◽  
Muscle Invasive

307 Background: Advances in IGART offer individualized solutions to improve target coverage and reduce normal tissue irradiation allowing opportunity to increase radiation tumour dose and spare normal bladder. Methods: A library of 3 IMRT plans were created (small, medium and large) from planning CT scans performed at 30 and 60 minutes; treating whole bladder to 52 Gy and tumour to 70 Gy in 32 fractions. Where normal tissue dose constraints were not met consideration was made to boosting tumour to lower dose (68 Gy-64 Gy). Cone beam CT (CBCT) imaging was performed prior to each fraction. Appropriate PTV was selected from the library for treatment delivery. Post treatment CBCT was acquired weekly in order to assess intra-fraction filling and coverage. Results: 22 patients have been planned using this technique. All have met tissue constraints for treatment to 70 Gy. 21 patients have completed radiotherapy, 18 completed treatment to 70 Gy; 1 patient was planned and treated to 68 Gy prior to dose escalation using this technique; 1 patient was treated to a total dose of 65.6 Gy because dose limiting toxicity occurred before dose escalation. 572 CBCTs have been evaluated. Treatment was delivered using small, medium, and large plans in 35%, 52%, and 13% cases respectively. Mean intra-fraction filling was 14 cm3 (SD 16.3, range 0.23-107.9). Mean time between pre- and post-CBCTs was 13 min (SD 2.1, range 9-18). Mean D 98% as assessed on post-radiotherapy CBCT was 98.7% (SD 1.78, range 89.9-100%). At median follow-up of 8 months (range 1-24 months), 18 patients remain alive and disease free. 2 superficial recurrences and 3 deaths from metastatic bladder cancer have occurred. No muscle invasive recurrences have occurred within this cohort. Using this technique one patient has experienced late toxicity (grade 3 cystitis) 5.3 months after radiotherapy (now resolved). Conclusions: IGART using IMRT to delivery a simultaneous integrated tumour boost is feasible with acceptable toxicity. Trial recruitment continues at 70 Gy and will be evaluated in a randomised trial (RAIDER). Clinical trial information: NCT01124682.

Salvage radiation therapy after radical prostatectomy: Contribution of a dose escalation to macroscopic local relapses.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. e634-e634
Author(s):  
Imad Eddine Selmaji ◽  
Corina Udrescu ◽  
Tristan Brahmi ◽  
Hamza Samlali ◽  
Ariane Lapierre ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Radical Prostatectomy ◽  
Local Control ◽  
Dose Escalation ◽  
Local Control Rate ◽  
Salvage Radiation Therapy ◽  
Gi Toxicity ◽  
A New Technique ◽  
Targeted Mri

e634 Background: Salvage radiation therapy (RT) after radical prostatectomy (RP) for prostate cancer using 66 Gy may not be enough to treat macroscopic disease. The presence of a macroscopic nodule on the MRI could justify a focal dose escalation. This study evaluates the tolerance and efficacy of a new technique of irradiation including a focal boost to the nodule. Methods: Between 2011 and 2015, 14 patients, with a macroscopic relapse diagnosed on the MRI, underwent targeted MRI-guided biopsies. Three gold markers were implanted into the prostatic bed for a more accurate MRI/CT fusion and image guided IMRT. A dose of 60 Gy was delivered to the prostatic bed followed by a dose escalation to 72Gy on the macroscopic nodule. Acute and late genitourinary (GU) and gastrointestinal (GI) toxicities were evaluated using the CTCAE v4. PSA level and late toxicities were assessed at 1 month and then every 6 months for 3 years. Results: The mean follow-up was 26.2 [18 – 36] months. Two patients had a biochemical failure after salvage RT (one bone metastasis and one lymph node recurrence). The local control rate was 100% and the biochemical control rate was 85.7%. Results for acute and late toxicities are summarized in the table. One patient presented with grade 2 urinary toxicity during the prostatic bed irradiation which lowered to grade 1 when the dose was focalized to the nodule. No grade 2 acute GI toxicity was seen. All late GI and GU toxicities were grade 1. Conclusions: Dose escalation to the macroscopic nodule visible on MRI is feasible using an IMRT-IGRT approach with gold makers. This technique allows a perfect initial local control at 3 years with a good tolerance. [Table: see text]

Accounting with a lessor — a manufacturer of expensive medical equipment

2021 ◽  
pp. 6-19
Author(s):  
Lyudmila Viktorovna Sotnikova
Keyword(s):  
Radiation Therapy ◽  
Proton Therapy ◽  
Medical Equipment ◽  
Proton Accelerator ◽  
Proton Radiation ◽  
Proton Radiation Therapy ◽  
Financial Result

The article deals with the features of reflection in the accounting of organizations that are manufacturers of expensive medical equipment, the transfer of this medical equipment to non-operational (financial) lease to medical organizations. The article reviews the possibilities of proton therapy, manufacturers of equipment for proton therapy, including Russian ones. It is Russian manufacturers who are actively working on the development of compact proton accelerator samples that can be placed in any, not only specialized medical organizations. The article presents an example of accounting for accounting objects (revenue, cost, financial result (profit/loss)) arising on the date of conclusion of the contract of non-operational (financial) lease of equipment for proton radiation therapy.

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