Physical and Biological Basis of Proton and of Carbon Ion Radiation Therapy and Clinical Outcome Data

2009 ◽  
Vol 02 (01) ◽  
pp. 1-15 ◽  
Author(s):  
Herman Suit ◽  
Thomas F. Delaney ◽  
Alexei Trofimov
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
Dose Distribution ◽  
Particle Beam ◽  
Initial Energy ◽  
Outcome Data ◽  
Ion Beams ◽  
Phase Iii ◽  
Dose Fractionation ◽  
Carbon Ion

There is a clear basis in physics for the clinical use of proton and carbon beams in radiation therapy, namely, the finite range of the particle beam. The range is dependent on the beam initial energy, density and atomic composition of tissues along the beam path. Beams can be designed that penetrate to the required depth and deliver a uniform biologically effective dose across the depth of interest. The yield is a superior dose distribution relative to photon beams. There is a potential clinical advantage from the high linear energy transfer (LET) characteristics of carbon beams. This is based on a lower oxygen enhancement ratio (OER) and a flatter age response function. However, due to uncertainties relating OER with relative biological effectiveness (RBE), there is no clinical evidence to date that carbon ion beams have an advantage over proton beams. We strongly support performance Phase III clinical trials of protons vs carbon ion beams designed to feature a single variable, LET. Dose fractionation would be identical in both arms and dose distribution would be similar for the sites to be tested. For sites for which the carbon beam has a demonstrated important advantage in comparative treatment planning due to the narrower penumbra would not be selected for the clinical trials.

scholarly journals Radiation Therapy Oncology Group (RTOG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 411-418
Author(s):  
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
Radiation Therapy Oncology Group ◽  
Phase Iii ◽  
Partial Breast Irradiation ◽  
List Type ◽  
Breast Irradiation ◽  
Oncology Group ◽  
Duct Carcinoma ◽  
Conformal Radiation Therapy

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Radiation therapy Oncology group (RTOG). Clinical trials include: RTOG 9804: Phase III trial of observation ± tamoxifen versus RT ± tamoxifen for good risk duct carcinoma in-situ(DCIS) of the female breast.NSABP B-39/RTOG 0413: A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, or II breast cancer.A phase II trial to evaluate three dimensional conformal radiation therapy (3D-RT) confined to the region of the lumpectomy cavity for stage I and II breast carcinoma.

scholarly journals Clinical trials involving carbon‐ion radiation therapy and the path forward

Cancer ◽  
2018 ◽  
Vol 124 (23) ◽  
pp. 4467-4476 ◽  
Author(s):  
Ann A. Lazar ◽  
Reinhard Schulte ◽  
Bruce Faddegon ◽  
Eleanor A. Blakely ◽  
Mack Roach
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
Carbon Ion

Alliance for clinical trials in oncology trial A021501: Preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4151-TPS4151 ◽  
Author(s):  
Matthew H. G. Katz ◽  
Fang-Shu Ou ◽  
Joseph Herman ◽  
Syed A. Ahmad ◽  
Brian M. Wolpin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
De Novo ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
R0 Resection ◽  
Preoperative Treatment ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Oncology Trial

TPS4151 Background: Borderline resectable pancreatic cancers infiltrate into adjacent vascular structures to an extent that makes an R0 resection unlikely when pancreatectomy is performed de novo. In a pilot study, Alliance for Clinical Trials in Oncology Trial A021101, the median survival of patients who received chemotherapy and radiation prior to anticipated pancreatectomy was 22 months, and an R0 resection was achieved in 64% of operations. However, the individual contributions of preoperative chemotherapy and radiation therapy are poorly defined.This study, Alliance for Clinical Oncology Trial A021501, will help define a standard preoperative treatment regimen for borderline resectable pancreatic cancer and position the superior arm for further evaluation in future phase III trials. Methods: In this recently activated randomized phase II trial, 134 patients with a biopsy-confirmed pancreatic ductal adenocarcinoma that meets centrally-reviewed radiographic criteria for borderline resectable disease are randomized to receive either 8 cycles of modified FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2 and infusional 5-fluorouracil 2400 mg/m2 for 4 cycles) or to 7 cycles of modified FOLFIRINOX followed by stereotactic body radiation therapy (33-40 Gy in 5 fractions). Patients without evidence of disease progression following preoperative therapy undergo pancreatectomy and subsequently receive 4 cycles of postoperative modified FOLFOX6 (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and infusional 5-fluorouracil 2400 mg/m2 for 4 cycles). The primary endpoint is the 18-month overall survival rate of patients enrolled into each of the two treatment arms. An interim analysis of the R0 resection rate within each arm will be conducted to assess treatment futility after accrual of 30 patients. Secondary endpoints include rates of margin-negative resection and event-free survival. The trial is activated nationwide and eligible to be opened for accrual at any National Clinical Trials Network cooperative group member site. Clinical trial information: NCT02839343.

scholarly journals Risks of using pre-event time scale and ordinal scale measurements in COVID-19 clinical trials

2021 ◽  
pp. 32-37
Author(s):  
M.V. Yashchenko
Keyword(s):  
Clinical Trials ◽  
Clinical Outcome ◽  
Oxygen Therapy ◽  
Resource Dependence ◽  
Hospital Admissions ◽  
Outcome Data ◽  
Phase Iii ◽  
Ordinal Scale ◽  
Time To Event ◽  
Ordinal Scales

BACKGROUND. The article shows the results of literature search and analysis of endpoints of interventional clinical trials of phase III-IV of the treatment of hospitalized patients with coronavirus disease (COVID-19) and of its prevention. MATERIALS AND METHODS. Among 102 trials found, ordinal scales were used in 60 trials, time-to-event outcome measures were used in 54 trials, both scales – in 49 trials. Time-to-event endpoints were related to hospitalization/intensive care unit term, discontinuation of oxygen therapy, and clinical improvement standardized on ordinal scales. At the same time, the early discontinuation of oxygen therapy and the early discharge create risks to the biometric measurement. RESULTS AND DISCUSSION. Statistical calculations showed the association of the number of new COVID-19 hospital admissions per day with the percentage of free beds, but not only with the number of new coronavirus infection cases in general, the number of deaths and the number of people recovering from COVID-19 per day in different regions of Ukraine. These results may indicate that resource-dependence and organizational aspects affect the hospitalization of patients with COVID-19. CONCLUSIONS. Therefore, to ensure that the discharge or discontinuation of oxygen therapy was due solely to a positive clinical outcome, data on changes of number of beds, access to oxygen supplies as well as data relevant to determination of the desired clinical outcome (body temperature, oxygen saturation, severity of symptoms, etc.) should be collected. It is recommended to collect biomarker data after discharge, if possible.

scholarly journals Treatment-Related Adverse Effects in Lung Cancer Patients after Stereotactic Ablative Radiation Therapy

2018 ◽  
Vol 2018 ◽  
pp. 1-16 ◽  
Author(s):  
Stamati Morias ◽  
Loredana G. Marcu ◽  
Michala Short ◽  
Eileen Giles ◽  
Andrew Potter ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Radiation Therapy ◽  
Early Stage ◽  
Statistical Significance ◽  
Phase Iii ◽  
Treatment Technique ◽  
Phase Ii Trials ◽  
Safe Treatment ◽  
Stereotactic Ablative Radiation Therapy

Introduction. Lung cancer is a disease which, despite the advancements in treatment, still has a very poor 5-year survival rate. Stereotactic ablative radiation therapy (SABR) is a highly advanced, sophisticated, and safe treatment which allows patients with early stage lung cancer to be treated effectively without invasive procedures and with excellent clinical outcomes. Avoiding surgery minimises morbidity and recovery time, bettering patients’ quality of life. Furthermore, SABR allows patients unsuitable for surgery to still undergo curative treatment. Methods. We aimed to review SABR-related normal tissue toxicities reported in the literature. While many studies assess safety, clinical efficacy, and disease control of SABR for lung cancer, the number of comprehensive reviews that analyse SABR-related side-effects is scarce. This integrative review summarises the toxicities reported in literature based on published clinical trials and tumour location (central or peripheral tumours) for available SABR techniques. Given that the majority of the clinical studies did not report on the statistical significance (e.g., p-values and confidence intervals) of the toxicities experienced by patients, statistical analyses cannot be performed. As a result, adverse events are compiled from clinical reports; however, due to various techniques and nonstandard toxicity reports, no meta-analysis is possible at the current stage of reported data. Results. When comparing lobectomy and SABR in phase III trials, surgery resulted in increased procedure-related morbidity. In phase II trials, very few studies showed high grade toxicities/fatalities as a result of SABR for lung cancer. Gross target volume size was a significant predictor of toxicity. An ipsilateral mean lung dose larger than 9 Gy was significantly associated with radiation pneumonitis. Conclusions. Based on the studies reviewed SABR is a safe treatment technique for lung cancer; however, further well-designed phase III randomised clinical trials are required to produce timely conclusive results and to enable their comparison and statistical analysis.

scholarly journals EP-1192: Assessment of quality of life in phase III clinical trials of radiation therapy in breast cancer

2017 ◽  
Vol 123 ◽  
pp. S645-S646
Author(s):  
G.N. Marta ◽  
F.Y. Moraes ◽  
E.T. Leite ◽  
E. Chow ◽  
D. Cella ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Radiation Therapy ◽  
Phase Iii ◽  
Phase Iii Clinical Trials

scholarly journals Particle Beam Therapy for Cancer of the Skull Base, Nasal Cavity, and Paranasal Sinus

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Nobuyoshi Fukumitsu
Keyword(s):  
Nasal Cavity ◽  
Skull Base ◽  
Paranasal Sinus ◽  
Ion Beam ◽  
Particle Beam ◽  
Ion Beams ◽  
Carbon Ion ◽  
Carbon Ion Beam ◽  
Future Direction ◽  
Particle Beam Therapy

Particle beam therapy has been rapidly developed in these several decades. Proton and carbon ion beams are most frequently used in particle beam therapy. Proton and carbon ion beam radiotherapy have physical and biological advantage to the conventional photon radiotherapy. Cancers of the skull base, nasal cavity, and paranasal sinus are rare; however these diseases can receive the benefits of particle beam radiotherapy. This paper describes the clinical review of the cancer of the skull base, nasal cavity, and paranasal sinus treated with proton and carbon ion beams, adding some information of feature and future direction of proton and carbon ion beam radiotherapy.

scholarly journals Hypofractionated and hyper-hypofractionated radiation therapy in postoperative breast cancer treatment

2020 ◽  
Vol 66 (9) ◽  
pp. 1301-1306
Author(s):  
Marcel Fang ◽  
Gustavo Nader Marta
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Radiation Therapy ◽  
Cancer Patients ◽  
Phase Iii ◽  
Long Term Results ◽  
Adjuvant Radiation ◽  
Breast Cancer Patients ◽  
Safety And Efficacy

SUMMARY INTRODUCTION: Radiation therapy is widely used as adjuvant treatment in breast cancer patients. In the last decades, several studies have been designed to evaluate the safety and efficacy of hypofractionated breast radiation therapy. More recently, even shorter regimens with doses above 4 Gy (hyper-hypofractionation) have also been proposed. This study aims to present a narrative review of the various hypofractionation protocols used to treat breast cancer patients with a focus on clinical application. RESULTS: Long-term results from several phase III randomized controlled trials demonstrated the safety and efficacy of hypofractionated breast radiation therapy using 15 or 16 fractions for early and locally advanced disease. The results of the initial clinical trials of hyper-hypofractionation are also encouraging and it is believed that these regimens may become routine in the indication of adjuvant radiation therapy treatment after the ongoing studies on this subject have matured. CONCLUSIONS: The idea that normal tissues could present high toxicity at doses above 2 Gy was opposed by clinical trials that demonstrated that moderate hypofractionation had similar results regarding oncological and cosmetic outcomes compared to conventional fractionation. Cosmetic and toxicity results from hyper-fractionation studies are in principle favorable. However, the long-term oncological results of studies that used hyper-hypofractionation for the treatment of breast cancer patients are still awaited.

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