Feasibility RCT of definitive chemoradiotherapy or chemotherapy and surgery for oesophageal squamous cell cancer

Blazeby, Jane M; Strong, Sean; Donovan, Jenny; Wilson, Caroline; Hollingworth, William; Crosby, Tom; Nicklin, James L.; Falk, Stephen; Barham, C. P.; Hollowood, Andrew; Streets, Christopher G.; Titcomb, Dan; Krysztopik, Richard; Griffin, S. M.; Brookes, Sara

doi:10.1038/bjc.2014.313

Cited by 31 publications

(55 citation statements)

References 28 publications

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“…Many studies (23/35) explored recruitment issues within the context of a single RCT [13,[23][24][25][30][31][32][33][36][37][38][39][40]42,44,[46][47][48][51][52][53][54]56], whilst eight provided a synthesis of results from multiple RCTs [26][27][28]41,45,49,50,55]. Four studies sampled healthcare professionals who recruited to RCTs generally, rather than a specific trial [29,34,35,43].…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Recruiters were from urological cancer trials [13,23,25,27,28,40,41,44,55], other cancer trials [24,27,28,32,35,40,44,49,50,52,54,55], mental health [27,28,39,46,50,55], orthopaedics [31,33,38,49,56], diabetes [36,47], vascular surgery [40,49], peripartum trials [37,53], HIV [30], smoking cessation [42], and pressure area care [51]. The majority of studies (32/35) focused on RCTs that were conducted in the UK [13,[24][25][26][27][28][29][31][32]…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…The majority of studies (32/35) focused on RCTs that were conducted in the UK [13,[24][25][26][27][28][29][31][32][33][34][35][36][37][38][39][40][41][43][44][45][46][47][48][49][50][51][52][53][54][55][56].…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Studies consisted mostly of interviews or focus groups with those involved in recruitment to RCTs [13,[23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]39,[42][43][44][46][47][48][49][50][51][52][53][54][55][56], sometimes alongside interviews with patients who had been offered the opportunity to join the trial [23][24][25][26]33,37]. Several studies audio recorded consultations where recruiters discussed the RCT with eligible patients [13,[24][25][26]31,32,38,40,41,44,45,49,…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Several studies audio recorded consultations where recruiters discussed the RCT with eligible patients [13,[24][25][26]31,32,38,40,41,44,45,49,50,52,55]…”

Section: Summary Of Included Papersmentioning

confidence: 99%

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Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Context: The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. Objective: This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improverecruitment and informed consent within a range of clinical trials. Evidence acquisition: A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. Evidence synthesis: The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Conclusions: Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Patient summary: Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.

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Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Several studies audio recorded consultations where recruiters discussed the RCT with eligible patients [13,[24][25][26]31,32,38,40,41,44,45,49,50,52,55]…”

Section: Summary Of Included Papersmentioning

confidence: 99%

See 3 more Smart Citations

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Non-surgical versus surgical treatment for oesophageal cancer

Best

Mughal

Gurusamy

2016

Cochrane Database of Systematic Reviews

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Based on low quality evidence, chemoradiotherapy appears to be at least equivalent to surgery in terms of short-term and long-term survival in people with oesophageal cancer (squamous cell carcinoma type) who are fit for surgery and are responsive to induction chemoradiotherapy. However, there is uncertainty in the comparison of definitive chemoradiotherapy versus surgery for oesophageal cancer (adenocarcinoma type) and we cannot rule out significant benefits or harms of definitive chemoradiotherapy versus surgery. Based on very low quality evidence, the proportion of people with dysphagia at the last follow-up visit prior to death was higher with definitive chemoradiotherapy compared to surgery. Based on very low quality evidence, radiotherapy results in less long-term survival than surgery in people with oesophageal cancer who are fit for surgery. However, there is a risk of bias and random errors in these results, although the risk of bias in the studies included in this systematic review is likely to be lower than in non-randomised studies.Further trials at low risk of bias are necessary. Such trials need to compare endoscopic treatment with surgical treatment in early stage oesophageal cancer (carcinoma in situ and Stage Ia), and definitive chemoradiotherapy with surgical treatments in other stages of oesophageal cancer, and should measure and report patient-oriented outcomes. Early identification of responders to chemoradiotherapy and better second-line treatment for non-responders will also increase the need and acceptability of trials that compare definitive chemoradiotherapy with surgery.

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Multidisciplinary treatment of esophageal cancer: The role of active surveillance after neoadjuvant chemoradiation

Triantafyllou

Wijnhoven

2020

Annals of Gastroent Surgery

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Esophageal cancer (EC) is an aggressive disease. The two most common types of EC are adenocarcinoma (AC) and squamous cell carcinoma (SCC). AC and SCC differ with regard to etiology, geographic distribution, response to chemotherapy/ radiotherapy, prognosis and possibly need for surgical resection. Esophagectomy is the cornerstone in the treatment of EC. During the last two decades, studies on the lymph node dissection during esophagectomy have shown improved survival in patients who underwent an extensive nodal dissection. 1 A total number of 23 lymph nodes were proposed as the optimal threshold in order to achieve a maximal survival benefit after esophagectomy. The extent of lymph node dissection expressed as the total number of nodes dissected was found to be an independent predictor of survival. 2 Whether the observed relationship between the number of nodes dissected and survival reflects a true benefit of more extensive surgery or is due to stage migration, is not clear yet. However, a transthoracic esophagectomy with a two-field nodal dissection is considered by many as the standard surgical approach nowadays. Esophagectomy is associated with major complications. 3-4 The diminished quality of life of patients after neoadjuvant therapy plus esophagectomy is another drawback. A patient's quality of life is substantially impaired after surgery including role and social functioning. 5 Reducing morbidity after esophagectomy is a challenge. The application of minimally invasive surgical techniques, better selection of surgical candidates, preoptimization of patient condition, and enhanced recovery protocols have shown to be associated with a reduction in complications and quicker return to normal functioning. 6-10

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Feasibility RCT of definitive chemoradiotherapy or chemotherapy and surgery for oesophageal squamous cell cancer

Cited by 31 publications

References 28 publications

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Non-surgical versus surgical treatment for oesophageal cancer

Multidisciplinary treatment of esophageal cancer: The role of active surveillance after neoadjuvant chemoradiation

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