Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 12/2013

01-11-2013 | Healthcare Policy and Outcomes

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

Authors: Amber S. Menezes, MD, Alison Barnes, MD, Adena S. Scheer, MD, MSc, FRCS(C), Guillaume Martel, MD, MSc, FRCS(C), Husein Moloo, MD, MSc, FRCS(C), Robin P. Boushey, MD, PhD, CIP, FRCS(C), Elham Sabri, MSc, Rebecca C. Auer, MD, MSc, FRCS(C)

Published in: Annals of Surgical Oncology | Issue 12/2013

Login to get access

Abstract

Background

The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology 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.

Results

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 %).

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. 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.
Literature
1.
2.
3.
Panesar SS, Thakrar R, Athanasiou T, Sheikh A. Comparison of reports of randomized controlled trials and systematic reviews in surgical journals: literature review. J R Soc Med. 2006;99:470–2.PubMedCrossRef
4.
Wente MN, Seiler CM, Uhl W, Büchler MW. Perspectives of evidence-based surgery. Dig Surg. 2003;20:263–9.PubMedCrossRef
5.
Howes N, Chagla L, Thorpe M, McCulloch P. Surgical practice is evidence based. Br J Surg. 1997;84:1220–3.PubMedCrossRef
6.
Ellis J, Mulligan I, Rowe J, Sackett DL. Inpatient general medicine is evidence based. Lancet. 1995;364:407–10.
7.
8.
Bailey CS, Fehlings MG, Rampersaud YR, Hall H, Wai EK, Fisher CG, et al. Industry and evidence-based medicine: believable or conflicted? A systematic review of the surgical literature. Can J Surg. 2011;54:321–6.PubMedCrossRef
9.
Okike K, Kocher MS, Mehlman CT, Bhandari M. Conflict of interest in orthopaedic research: an association between findings and fundings in scientific presentations. J Bone Joint Surg. 2007;89:608–13.PubMedCrossRef
10.
Pitak-Arnnop P, Sader R, Rapidis AD, Dhanuthai K, Bauer U, Herve C, et al. Publication bias in oral and maxillofacial surgery journals: an observation on published controlled trials. J Craniomaxillofac Surg. 2010;38:4–10.PubMedCrossRef
11.
Kanaan Z, Galandiuk S, Abby M, Shannon KV, Dajani D, Hicks N, et al. The value of lesser-impact-factor surgical journals as a source of negative and inconclusive outcomes reporting. Ann Surg. 2011;253:619–23.PubMedCrossRef
12.
13.
McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D, et al. Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324:1448–51.PubMedCrossRef
14.
Sekeres M, Gold JL, Chan A, Lexchin J, Moher D, Van Laethem ML, et al. Poor reporting of scientific leadership information in clinical trial registers. PLoS One. 2008;3:e1610.PubMedCrossRef
15.
16.
Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The clinicaltrials.gov results database – update and key issues. N Engl J Med. 2011;364:852–60.PubMedCrossRef
17.
18.
Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in clinicaltrials.gov, 2007–2010. JAMA. 2012;307:1838–47.PubMedCrossRef
19.
Zarin DA, Tse T, Ide NC. Trial registration at clinicaltrials.gov between May and October 2005. N Engl J Med. 2005;353:2779–87.PubMedCrossRef
20.
Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in clinicaltrials.gov: a cross-sectional analysis. PLoS Med. 2009;6:e1000144.PubMedCrossRef
21.
Huic M, Marusic M, Marusic A. Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy. PLoS One. 2011;6:e25258.PubMedCrossRef
22.
23.
24.
Ramsey S, Scoggins J. Practicing on the tip of an information iceberg? Evidence of underpublication of registered clinical trials in oncology. Oncologist. 2008;13:925–9.PubMedCrossRef
25.
Van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, et al. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000;92:1143–50.PubMedCrossRef
26.
Jayne DG, Thorpe HC, Copeland J, Quirke P, Brown JM, Guillou PJ. Five-year follow-up of the Medical Research Council CLASICC trial of laparoscopically assisted versus open surgery for colorectal cancer. Br J Surg. 2010;97:1638–45.PubMedCrossRef
27.
d’Amato TA, Ashrafi AS, Schuchert MJ, Alshehab DS, Seely AJ, Shamji FM, et al. Risk of pneumonectomy after induction therapy for locally advanced non-small cell lung cancer. Ann Thor Surg. 2009;88:1079–85.PubMedCrossRef
28.
Angarita FA, Acuna SA, Torregrosa L, Tawil M, Escallon J, Ruíz Á. Perioperative variables associated with surgical site infection in breast cancer surgery. J Hosp Infect. 2011;79:328–32.PubMedCrossRef
29.
Thornton AD, Ravn P, Winslet M, Chester K. Angiogenesis inhibition with bevacizumab and the surgical management of colorectal cancer. Br J Surg. 2006;93:1456–63.PubMedCrossRef
30.
Wright G, Manser RL, Byrnes G, Hart D, Campbell DA. Surgery for non-small cell lung cancer: systematic review and meta-analysis of randomised controlled trials. Thorax. 2006;61:597–603.PubMedCrossRef
31.
McLeod RS, Wright JG, Solomon MJ, Hu X, Walters BC, Lossing Al. Randomized controlled trials in surgery: issues and problems. Surgery. 1996;119:483–6.PubMedCrossRef
32.
Farrokhyar F, Karanicolas PJ, Thoma A, Simunovic M, Bhandari M, Devereaux PJ, et al. Randomized controlled trials of surgical interventions. Ann Surg. 2010;251:409–16.PubMedCrossRef
33.
Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009;10:9.PubMedCrossRef
34.
Ramsay CR, Grant AM, Wallace SA, Garthwaite PH, Monk AF, Russell IT. Statistical assessment of the learning curves of health technologies. Health Technol Assess. 2001;5:1–79.PubMed
35.
Young JM, Solomon MJ, Harrison JD, Salkeld G, Butow P. Measuring patient preference and surgeon choice. Surgery. 2008;143:582–8.PubMedCrossRef
Metadata
Title
Clinical Research in Surgical Oncology: An Analysis of ClinicalTrials.gov
Authors
Amber S. Menezes, MD
Alison Barnes, MD
Adena S. Scheer, MD, MSc, FRCS(C)
Guillaume Martel, MD, MSc, FRCS(C)
Husein Moloo, MD, MSc, FRCS(C)
Robin P. Boushey, MD, PhD, CIP, FRCS(C)
Elham Sabri, MSc
Rebecca C. Auer, MD, MSc, FRCS(C)
Publication date
01-11-2013
Publisher
Springer US
Published in
Annals of Surgical Oncology / Issue 12/2013
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-013-3054-y

Other articles of this Issue 12/2013

Annals of Surgical Oncology 12/2013 Go to the issue

Gastrointestinal Oncology

Clinical and Immunological Impact of Early Postoperative Enteral Immunonutrition After Total Gastrectomy in Gastric Cancer Patients: A Prospective Randomized Study

Endocrine Tumors

Discriminating Pheochromocytomas from Other Adrenal Lesions: The Dilemma of Elevated Catecholamines

Breast Oncology

Clinically Meaningful Tumor Reduction Rates Vary by Prechemotherapy MRI Phenotype and Tumor Subtype in the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657)

Melanomas

Reproducibility of AJCC Staging Parameters in Primary Cutaneous Melanoma: An Analysis of 4,924 Cases

Gynecologic Oncology

The Role of Lymphadenectomy in Cervical Cancer Patients: The Significance of the Number and the Status of Lymph Nodes Removed in 526 Cases Treated in a Single Institution

Thoracic Oncology

Different Recurrence Pattern After Neoadjuvant Chemoradiotherapy Compared to Surgery Alone in Esophageal Cancer Patients