Clinical Trials In Surgical Oncology Research Articles

Analysis of Registered Clinical Trials in Surgical Oncology, 2008-2020

This quality improvement study characterizes surgical oncology trials, analyzes growth, identifies associations with early discontinuation or results reporting, and evaluates proportions of trials involving each neoplasm site.

What can we learn from oncology surgical trials?

Conducting high-quality prospective clinical trials in surgical oncology remains a challenge, and many seemingly well-designed trials lack this high quality because of inadequate recruitment accrual, lack of clinician interest, or evolution of treatment strategy during the many years over which such trials are conducted. In this Perspectives we examine some of the failures in published surgical oncology trials and discuss why they failed, and we make a critical assessment of the established prospective trial methodology in oncological practice (that is, phase 0, I, II, III and IV trials, and large prospective comparative audits) and how these methods might be used more effectively in future evaluation of cancer-surgery practice.

Clinical Research in Surgical Oncology: An Analysis of ClinicalTrials.gov

The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov. Data was extracted from ClinicalTrials.gov using the following search engine criteria: "Cancer" as Condition, "Surgery OR Operation OR Resection" as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. Of 9,961 oncology trials, 1,049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%, 1.3% of all oncology trials) assessed a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2%) focused on surgical techniques or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6%). The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making.

Clinical research in surgical oncology: An analysis of clinicaltrials.gov.

591 Background: The conduction of randomized clinical trials has expanded in medical specialties, but to a far lesser degree in surgery. This is due to design challenges with standardization of treatment, blinding and lack of surgeon equipoise. The objective of this study was to assess the current landscape of clinical trials in surgical oncology registered at clinicaltrials.gov. Methods: Data was extracted from clinicaltrials.gov using the following search engine criteria: ‘Cancer’ as Condition, ‘Surgery OR Operation OR Resection’ as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. The search was performed on March 23, 2011 by three investigators in parallel. The total number of oncology trials was also obtained. Results: Of 9990 oncology trials, 1049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%; 1.3% of all oncology trials) manipulated a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Trials assessing adjuvant therapies focused on systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%). Of the 125 trials where surgery was the manipulated variable, 59 trials (47.2%) focused on surgical techniques (including minimally invasive) or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery vs. no surgery. The majority of the 125 trials were non- randomized (72, 57.6%), and Phase III trials accounted for less than one-quarter (29, 23.2%). Conclusions: The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies, and are frequently non-randomized. Randomized surgical oncology trials account for &lt;1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified to facilitate higher-level evidence in surgical decision making.

Health-Related Quality of Life Measurement in Randomized Clinical Trials in Surgical Oncology

There is debate about the value of measuring health-related quality of life (HRQL) in clinical trials in oncology because of evidence suggesting that HRQL does not influence clinical decisions. Analysis of HRQL in surgical trials, however, may inform decision making because it provides detailed assessment of the immediate detrimental short-term impact of surgery on HRQL that needs to be considered against the long-term survival benefits and functional outcomes of surgery. This study evaluated whether HRQL in randomized trials in surgical oncology contributes to clinical decision making. A systematic review identified randomized trials in surgical oncology with HRQL. Trials were evaluated independently by two reviewers and the value of HRQL in clinical decision making was categorized in three ways: whether trial investigators reported that HRQL influenced final treatment recommendations, whether trial investigators reported that HRQL would be useful for informed consent, and whether HRQL was assessed robustly according to predefined criteria. Thirty-three randomized trials with valid HRQL questionnaires were identified; 22 (67%) concluded that HRQL outcomes influenced treatment decisions or provided valuable data for informed consent, and seven of these trials had robust HRQL design. Another five trials had robust HRQL design but investigators reported that HRQL outcomes were not clinically important enough to influence treatment recommendations. In surgical trials in oncology, HRQL informed clinical decision making. It is recommended that HRQL be included in relevant surgical trials, and that information be used to inform clinicians and patients about the impact of surgery on short- and long-term HRQL.

Clinical Trials in Surgical Oncology—Introduction

Clinical Trials in Surgical Oncology—Introduction

Basic principles in the planning of clinical trials in surgical oncology

BACKGROUND: ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) provides guidelines on the implementation of clinical trials. All study participants are obliged to follow these guidelines in line with "Good Clinical Practice". METHODS: The main features of a clinical study include the following items: Background and general aims, specific objectives, patient selection criteria, treatment schedules, methods of patient evaluation, trial design, registration and randomization of patients, patient consent, required size of study, monitoring of trial progress, forms and data handling, protocol deviations, plans for statistical analysis and administrative responsibilities. RESULTS: All items mentioned above should already be discussed in the planning stage of a clinical trial and addressed in the study protocol. The study protocol provides a guideline for any person involved in the trial. CONCLUSIONS: For the success of a clinical trial, it is especially important to have a clear and exact definition of the study hypotheses and to choose primary and secondary endpoints very carefully.

Trends in clinical trials in surgical oncology: Implications for outcomes research

Outcomes analysis in emerging as a crucial tool in understanding and improving health care. To this end, outcomes research is focused on methodologies for assessing the impact and quality of clinical services and the penetration of new findings. Clinical trials are an important mechanism for generating data to support outcomes research activities. In clinical trials in surgical oncology, there has been a general broadening of the spectrum of end points that are more focused on the needs of providing data to outcomes researchers. For example, in addition to traditional “mechanical” end points reflecting the physical dimensions of disability, awareness of the importance of end points related to quality of life has increased. Moreover, a variety of innovative study designs and methodologies have found more widespread use, including noninferiority trials, preresection staging designed to direct therapy more precisely, planned early reports of conditional results, prognostic studies, assessment of an event status at a point in time, and large simple trials. The goal of this article is to summarize and assess some of the trends in clinical trials in surgical oncology. Examples of ongoing studies or of trials in development from the American College of Surgeons Oncology Group are discussed.

Lessons from clinical trials in surgical oncology: time for a new paradigm?

Lessons from clinical trials in surgical oncology: time for a new paradigm?

Campaign strategy and tactics for clinical trials in surgical oncology

The strategic planning of the campaign against cancer and the employment of clinical trials on a national and supranational basis could be improved. Lessons and principles derived from other spheres of ordered activity might be usefully applied to the realm of clinical trials. Principles taught by military strategists may find practical applications in the development and prosecution of successful clinical trials of cancer therapy. In this paper we reflect upon the parallels and divergences between the principles of campaign strategy needed for the successful prosecution of military objectives and the efficient and effective prosecution of major clinical trials.

The (continued) importance of the hypothesis in surgical oncology research

There remains much to be learned about the biology and therapy of human solid tumours, despite remarkable progress in science, medicine and technology in the past century. The well-formulated, explicit and testable hypothesis remains the key to progress in scientific medicine. It should precede experiment and provide landmarks by which experimental results may be judged. Primary clinical research takes three common forms) Experimentation in surgical oncology often reports the measurement of a biological moiety in a laboratory model or series of clinical samples, and correlates it with actual or surrogate measures of outcome. Clinical trials in surgical oncology assess the value of an intervention, such as a modification in surgical technique, a new drug, or a new form of adjuvent therapy, on outcome. Surveys measure a parameter in a cohort of patients. Each form of research mandates a hypothesis. The scientific problem which underpins the scientific hypothesis may be a general or global issue, or it may be a subsidiary issue within a field of study. Unfortunately, many studies in surgical oncology lack a clear foundation hypothesis. This devalues much research effort, is scientifically inadequate and leads to a waste of human, clinical, laboratory and fiscal resources. This paper addresses the centrality of the hypothesis in the context of modern research processes and technologies.