Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

Mishra, Mark V.; Aggarwal, Sameer; Bentzen, Søren M.; Knight, Nancy; Mehta, Minesh P.; Regine, William F.

doi:10.1016/j.ijrobp.2016.10.045

Cited by 66 publications

(57 citation statements)

References 29 publications

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“…A comprehensive review of the evidence for PBRT was recently published . The authors of that review concluded that, although the proton therapy clinical trial portfolio was rapidly expanding, and most patients had been accrued to observational studies, they also acknowledged the need to evaluate those ongoing trials in terms of comparative effectiveness with conventional RT modalities.…”

Section: Introductionmentioning

confidence: 99%

“…A comprehensive review of the evidence for PBRT was recently published. 2 The authors of that review concluded that, although the proton therapy clinical trial portfolio was rapidly expanding, and most patients had been accrued to observational studies, they also acknowledged the need to evaluate those ongoing trials in terms of comparative effectiveness with conventional RT modalities. Most important, despite the comprehensiveness of their review, noticeably absent was any high-level evidence that proton-based treatment resulted in improved clinically significant results for any specific cancer type, site, or age group compared with other forms of RT.…”

Section: Introductionmentioning

confidence: 99%

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

Lazar

Schulte

Faddegon

et al. 2018

Cancer

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To describe the international landscape of clinical trials in carbon ion radiotherapy (CIRT), we reviewed the current status of 63 ongoing clinical trials (median: 47 subjects) involving CIRT identified from the clinicaltrials.gov trial registry and World Health Organization International Clinical Trials Platform Registry. We evaluated the potential for these trials to define the role of this modality in the treatment of specific cancer types, and to identify major challenges and opportunities to advance this technology. A significant body of literature suggests the potential for advantageous dose distributions and in preclinical biologic studies the enhanced effectiveness for CIRT compared to photons and protons. Additionally, clinical evidence, though limited, from phase I/II trials indicates the potential for CIRT to improve cancer outcomes. However, at present, high level phase III randomized clinical trial evidence does not exist. While 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. We propose several recommendations to study this modality in order to accelerate progress in the field, including to (1) increase the number of multi-national randomized clinical trials (2) leveraging existing CIRT facilities to launch larger multi-national 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 radiobiological research and pre-clinical testing.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Lazar

Schulte

Faddegon

et al. 2018

Cancer

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“…Although there is still a general paucity of data based on randomized clinical trials, its principle effectiveness, safety, and feasibility are no longer questioned. More than 100 prospective clinical trials are presently recruiting patients [1]. However, proton therapy is still an emerging technology (also in the field of breast cancer) that requires prospective data to identify the most suitable subgroup of patients within a specific disease entity for whom proton therapy will be of most value and result in a clinically significant difference over the use of photons.…”

Section: Introductionmentioning

confidence: 99%

Proton Therapy for Primary Breast Cancer

Hug¹

2018

Breast Care

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Proton therapy reduces the integral dose received by normal tissues due to its physical properties of dose deposition in the Bragg peak. In a small but significant percentage of patients requiring adjuvant radiotherapy (RT) for left-sided breast cancer, photon-based RT can lead to cardiac complications during long-term follow-up. The risk of cardiac complications is correlated with the dose to the coronary arteries and to the general ‘mean heart dose'. Dosimetric comparison analysis has identified advantages of proton therapy in accomplishing sparing of the heart with increasing target complexity while permitting uncompromised target coverage of the chest wall ± breast plus draining lymphatics. Early clinical data indicate good clinical tolerance to proton therapy without unexpected complications. Several clinical trials are presently ongoing to prospectively confirm a clinical benefit and to identify the subgroup of patients benefitting most from proton therapy for breast cancer.

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“…1 Over the last decade, there has been a rapid increase in the number of operating proton facilities in the United States, from 2 in 2003 to 22 in 2016. 2 While proton therapy utilization has continued to rise throughout the cancer community, there…”

Section: Introductionmentioning

confidence: 99%

Proton Therapy in the Treatment of Head and Neck Cancer

Katsoulakis¹,

Chernichenko²,

Schreiber³

et al. 2017

International Journal of Head and Neck Surgery

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Aim:To examine the value of proton therapy in relation to other treatment modalities in head and neck cancer.Review: Proton therapy has evolved into more sophisticated and costly intensity-modulated proton therapy and has resulted in even greater dose reduction to normal critical structures at risk as compared with photon therapy. Early clinical studies in head and neck cancers, especially for tumors of the skull base and paranasal sinuses, suggest that proton therapy is excellent in terms of local control and is comparable to intensity-modulated radiation therapy photons but with lower rates of morbidity.Results: There are many potential advantages to radiation therapy with protons. While there are many single institution studies examining the added value of protons to photon therapy, the value of proton therapy must be examined in prospective randomized clinical studies and across many subsites of head and neck cancer. Additional evidence is necessary to guide efficient clinical practice, patient selection, and tumors that are most likely to benefit from this treatment modality and justify proton therapy use given its significant cost.

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Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

Cited by 66 publications

References 29 publications

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

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

Proton Therapy for Primary Breast Cancer

Proton Therapy in the Treatment of Head and Neck Cancer

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