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Review
. 2018 Dec 1;124(23):4467-4476.
doi: 10.1002/cncr.31662. Epub 2018 Oct 11.

Clinical Trials Involving Carbon-Ion Radiation Therapy and the Path Forward

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Free PMC article
Review

Clinical Trials Involving Carbon-Ion Radiation Therapy and the Path Forward

Ann A Lazar et al. Cancer. .
Free PMC article

Abstract

To describe the international landscape of clinical trials in carbon-ion radiotherapy (CIRT), the authors reviewed the current status of 63 ongoing clinical trials (median, 47 participants) involving CIRT identified from the US clinicaltrials.gov trial registry and the World Health Organization International Clinical Trials Platform Registry. The objectives were to evaluate the potential for these trials to define the role of this modality in the treatment of specific cancer types and identify the major challenges and opportunities to advance this technology. A significant body of literature suggested the potential for advantageous dose distributions and, in preclinical biologic studies, the enhanced effectiveness for CIRT compared with photons and protons. In addition, clinical evidence from phase I/II trials, although limited, indicated the potential for CIRT to improve cancer outcomes. However, current high-level phase III randomized clinical trial evidence does not exist. Although there has been an increase in the number of trials investigating CIRT since 2010, and the number of countries and sites offering CIRT is slowly growing, this progress has excluded other countries. Several recommendations are proposed to study this modality to accelerate progress in the field, including: 1) increasing the number of multinational randomized clinical trials, 2) leveraging the existing CIRT facilities to launch larger multinational trials directed at common cancers combined with high-level quality assurance; and 3) developing more compact and less expensive next-generation treatment systems integrated with radiobiologic research and preclinical testing.

Keywords: carbon; clinical trials; heavy-ion radiotherapy; ions; particle therapy.

Conflict of interest statement

CONFLICT OF INTEREST DISCLOSURES: No conflicts of interest disclosures from any authors.

Figures

Figure 1A.
Figure 1A.
Schematic of the contemporary carbon ion radiation therapy facilities and gantries in Gunma, Japan showing the treatment rooms, ion source, synchrotron, and linear accelerator. Adapted from Noda et al., New Accelerator Facility for Carbon-Ion Cancer-Therapy. Journal of Radiation Research. 2007. 48: Suppl., A43-A54, by permission of Oxford University Press. 1B. Photo of the first carbon gantry built in Heidelberg, Germany shows the size of the gantry relative to a person. Reproduced with permission from Heidelberg University Hospital and the Heidelberg Ion-Beam Therapy Center.
Figure 1A.
Figure 1A.
Schematic of the contemporary carbon ion radiation therapy facilities and gantries in Gunma, Japan showing the treatment rooms, ion source, synchrotron, and linear accelerator. Adapted from Noda et al., New Accelerator Facility for Carbon-Ion Cancer-Therapy. Journal of Radiation Research. 2007. 48: Suppl., A43-A54, by permission of Oxford University Press. 1B. Photo of the first carbon gantry built in Heidelberg, Germany shows the size of the gantry relative to a person. Reproduced with permission from Heidelberg University Hospital and the Heidelberg Ion-Beam Therapy Center.
Figure 2:
Figure 2:
Summary of the expected (or intended) first year of enrollment of study trials extracted from the clinicaltrials.gov registry and WHO. Gold color indicates the total number of phase III clinical trials, dark blue color indicates the total number of phase II clinical trials, and light blue indicates the total number of phase I or phase I/II clinical trials.
Figure 3:
Figure 3:
Summary of the disease site extracted from the clinicaltrials.gov registry and WHO. Gold color indicates the total number of phase III clinical trials, dark blue color indicates the total number of phase II clinical trials, and light blue indicates the total number of phase I or phase I/II clinical trials. H&N denotes head and neck site and multiple denotes two or more sites.

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