scholarly journals Clinical Trials Evaluating Proton Therapy

2021 ◽  
Author(s):  
Paige A. Taylor

Although proton therapy was developed almost 80 years ago, widespread clinical implementation has been limited until the past decade. With the growing use of proton therapy, there is a desire to prove the equivalence or superiority of proton therapy across a number of cancer disease sites. Dozens of clinical trials have been developed to accomplish this within individual institutions, among a few centers, and across national and international networks such as the National Cancer Institute’s National Clinical Trial Network. The protocols include proton therapy imbedded in trials with photon therapy as well as randomized photon vs. proton trials. This chapter provides an overview of the design of such trials as well as some of the challenges facing protocols with proton therapy.

Stroke ◽  
2021 ◽  
Author(s):  
Jeyaraj Durai Pandian ◽  
Shweta Jain Verma ◽  
Deepti Arora ◽  
Meenakshi Sharma ◽  
Rupinder Dhaliwal ◽  
...  

Background and Purpose: Very few large scale multicentric stroke clinical trials have been done in India. The Indian Council of Medical Research funded INSTRuCT (Indian Stroke Clinical Trial Network) as a task force project with the objectives to establish a state-of-the-art stroke clinical trial network and to conduct pharmacological and nonpharmacological stroke clinical trials relevant to the nation and globally. The purpose of the article is to enumerate the structure of multicentric stroke network, with emphasis on its scope, challenges and expectations in India. Methods: Multiple expert group meetings were conducted by Indian Council of Medical Research to understand the scope of network to perform stroke clinical trials in the country. Established stroke centers with annual volume of 200 patients with stroke with prior experience of conducting clinical trials were included. Central coordinating center, standard operating procedures, data and safety monitoring board were formed. Discussion: In first phase, 2 trials were initiated namely, SPRINT (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India) and Ayurveda treatment in the rehabilitation of patients with ischemic stroke in India (RESTORE [Rehabilitation of Ischemic stroke Patients in India: A Randomized controlled trial]). In second phase, 4 trials have been approved. SPRINT trial was the first to be initiated. SPRINT trial randomized first patient on April 28, 2018; recruited 3048 patients with an average of 128.5 per month so far. The first follow-up was completed on May 27, 2019. RESTORE trial randomized first patient on May 22, 2019; recruited 49 patients with an average of 3.7 per month so far. The first follow-up was completed on August 30, 2019. Conclusions: In next 5 years, INSTRuCT will be able to complete high-quality large scale stroke trials which are relevant globally. REGISTRATION: URL: http://www.ctri.nic.in/ ; Unique Identifier: CTRI/2017/05/008507.


2011 ◽  
Vol 32 (5) ◽  
pp. 614-619 ◽  
Author(s):  
Lemuel A. Moyé ◽  
Shelly L. Sayre ◽  
Lynette Westbrook ◽  
Beth C. Jorgenson ◽  
Eileen Handberg ◽  
...  

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1527-1527
Author(s):  
Waqas Haque ◽  
Ann M. Geiger ◽  
Celette Sugg Skinner ◽  
Rasmi Nair ◽  
Simon Craddock Lee ◽  
...  

1527 Background: Patient accrual for cancer clinical trials is suboptimal. The complexity of applying eligibility criteria and enrolling patients may deter oncologists from recommending patients for a trial. As such, there is a need to understand how experience, training, and clinical decision support impact physician practices and intentions related to trial accrual. Methods: From May to September 2017, we conducted a survey on clinical trial accrual in a national sample of medical, surgical, and radiation oncologists. The 20-minute survey assessed barriers and facilitators to clinical trial accrual, including experience (e.g., “In the past 5 years, have you been a study or site PI of a trial?”), training (e.g., “Did you receive training about trial design and recruitment as part of medical school, residency, or fellowship? After fellowship?”), and clinical decision support (e.g., “What kind of clinical decision support has your practice implemented?). We used logistic regression to identify factors associated with frequency of discussing trials (with ≥25% of patients) and likelihood of recommending a trial to a patient (likely or very likely) in the future. Results: Survey respondents (n = 1,030) were mostly medical oncologists (59%), age 35-54 years (67%), male (74%), and not in academic practice (58%). About 18% of respondents (n = 183) reported discussing trials with ≥25% of their patients, and 80% reported being likely or very likely to recommend a trial to a patient in the future. Prior experience as principal investigator of a trial was associated with both frequency of discussing trials (OR 3.27, 95% CI 2.25, 4.75) and likelihood of recommending a trial in the future (OR 5.22, 95% CI 3.71, 7.34), as was receiving additional training in clinical trials after fellowship (discussion with patients: OR 2.48, 95% CI 1.80, 3.42; recommend in future: OR 1.92, 95% CI 1.37, 2.69). Implementing clinical decision support was not associated with discussing trials with ≥25% of patients (OR 1.12, 95% CI 0.76, 1.67), but was associated with being likely to recommend a trial in the future (OR 1.73, 95% CI 1.11, 2.71). Conclusions: In a national survey of oncologists, we observed differences in physician practices and intention related to clinical trial accrual. Whereas the vast majority (80%) reported being likely or very likely to recommend trials in the future, far fewer (20%) reported discussing trials with their patients within the past 5 years. Implementation of clinical decision support – electronic tools intended to optimize patient care and identification of patient eligibility – was not associated with frequency of past discussion of clinical trials but was associated with recommending a trial in the future. Given the stronger association between experience as a site Principal Investigator and recommending a trial, future research should explore how improving opportunities to lead a clinical trial impact trial accrual.


2016 ◽  
Vol 43 (6Part16) ◽  
pp. 3516-3517
Author(s):  
D Followill ◽  
J Galvin ◽  
J Michalski ◽  
M Rosen ◽  
T FitzGerald ◽  
...  

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17571-e17571
Author(s):  
Shayna Eliana Rich ◽  
Nancy Price Mendenhall

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.


2019 ◽  
Author(s):  
Huiyao Huang ◽  
Dawei Wu ◽  
Qi Fan ◽  
Jun Wang ◽  
Shuhang Wang ◽  
...  

Abstract Background: To analyze the time trend and regional difference of insurance coverage of cancer drug trials in mainland China for the past decade, thus to provide data support for the improvement and implementation of related policies, such as clinical trial insurance and ethical review in China. Methods: Based on the national authoritative database, “Drug Clinical Trial Registration and Information Disclosure Platform”, the time trend analysis of insurance coverage of cancer drug trials was conducted, from both the perspectives of trials and participants. Meanwhile, the group comparisons between seven regions, as well as different drug types and study phases, were also performed. Data processing and analysis were carried out using SAS 9.4. Mann-Kendall test was used for trend analysis, and chi-square test was used to conduct group comparisons. Results: A total of 1433 clinical trials were finally included, with 1153 (80.5%) trials being international. In average, the insurance rate of trials was 75.9%, and it was steadily increased by 7.8% annually. While the insurance coverage of Chinese participants was 58.8%, and it showed a wavy upward trend. Compared with international trials (90.0%), insurance rate of domestic trials (72.4%)) was significantly lower ( P < 0.001), but the rate gap decreased gradually. The comparisons by region showed that, the insurance rate for clinical trials in Northeast China (83.3%) was the highest, followed by South area (80.7%), North area (78.1%), and that for Northwest China (37.5%) was lowest. Compared with chemicals (74.8%) and biological products (79.9%), trials on traditional Chinese medicine had significantly lower rate of insurance (30.4%). For different study phase, insurance coverage in BE studies was the lowest (57.1%), followed by phase II trials, while it achieved the highest in phase III trials (85.1%). Conclusions: The insurance coverage of cancer drug trials in mainland China has been increasing steadily over the past decade. However, the regional differences are significant. To promote insurance coverage emphatically in underdeveloped areas could be our work emphasis in the near future. Although this study specially included cancer drug trials, the results could also provide reference for trials in all other fields.


Sign in / Sign up

Export Citation Format

Share Document