scholarly journals Oncosurgical Management of Liver Limited Stage IV Colorectal Cancer: Preliminary Data and Protocol for a Randomized Controlled Trial

2018 ◽  
Vol 7 (5) ◽  
pp. e125
Author(s):  
Paul Sutton ◽  
Dale Vimalachandran ◽  
Graeme Poston ◽  
Stephen Fenwick ◽  
Hassan Malik
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Preliminary Data ◽  
Controlled Trial ◽  
Stage Iv ◽  
Randomized Controlled ◽  
Limited Stage ◽  
Stage Iv Colorectal Cancer

scholarly journals Oncosurgical Management of Liver Limited Stage IV Colorectal Cancer: Preliminary Data and Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Paul Sutton ◽  
Dale Vimalachandran ◽  
Graeme Poston ◽  
Stephen Fenwick ◽  
Hassan Malik
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Future Development ◽  
Controlled Trial ◽  
Stage Iv ◽  
Trial Protocol ◽  
Randomized Controlled ◽  
Limited Stage ◽  
Stage Iv Colorectal Cancer ◽  
Preliminary Work

BACKGROUND Colorectal cancer is the fourth commonest cancer and second commonest cause of cancer-related death in the United Kingdom. Almost 15% of patients have metastases on presentation. An increasing number of surgical strategies and better neoadjuvant treatment options are responsible for more patients undergoing resection of liver metastases, with prolonged survival in a select group of patients who present with synchronous disease. It is clear that the optimal strategy for the management of these patients remains unclear, and there is certainly a complete absence of Level 1 evidence in the literature. OBJECTIVE The objective of this study is to undertake preliminary work and devise an outline trial protocol to inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. METHODS We have undertaken some preliminary work and begun the process of designing a randomized controlled trial and present a draft trial protocol here. RESULTS This study is at the protocol development stage only, and as such no results are available. There is no funding in place for this study, and no anticipated start date. CONCLUSIONS We have presented preliminary work and an outline trial protocol which we anticipate will inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We do not believe that the trial we have designed will answer the most significant clinical questions, nor that it is feasible to be delivered within the United Kingdom’s National Health Service at this current time.

scholarly journals Quality of Life for Patients With Incurable Stage IV Colorectal Cancer: Randomized Controlled Trial Comparing Resection Versus Endoscopic Stenting

In Vivo ◽  
2019 ◽  
Vol 33 (6) ◽  
pp. 2065-2070 ◽  
Author(s):  
ENRICO FIORI ◽  
ANTONIETTA LAMAZZA ◽  
ANTONIO V. STERPETTI ◽  
DANIELE CROCETTI ◽  
FRANCESCA DE FELICE ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Stage Iv ◽  
Endoscopic Stenting ◽  
Randomized Controlled ◽  
Stage Iv Colorectal Cancer

scholarly journals A randomized controlled trial comparing primary tumour resection plus chemotherapy with chemotherapy alone in incurable stage IV colorectal cancer: JCOG1007 (iPACS study)

2019 ◽  
Vol 50 (1) ◽  
pp. 89-93 ◽  
Author(s):  
Konosuke Moritani ◽  
Yukihide Kanemitsu ◽  
Dai Shida ◽  
Kohei Shitara ◽  
Junki Mizusawa ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Primary Tumour ◽  
Stage Iv ◽  
Tumour Resection ◽  
R0 Resection ◽  
Randomized Controlled ◽  
Stage Iv Colorectal Cancer ◽  
Primary Tumour Resection

Abstract It is controversial whether chemotherapy with or without primary tumour resection is effective for the patients with incurable Stage IV colorectal cancer. A randomized controlled trial, initiated in Japan in 2012, is being conducted to evaluate the survival benefit and safety of primary tumour resection plus chemotherapy compared with chemotherapy alone in asymptomatic Stage IV colorectal cancer patients with unresectable metastatic disease. Patients are randomly assigned to either chemotherapy alone or primary tumour resection followed by chemotherapy. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, incidence of adverse events, proportion of patients with R0 resection and proportion of palliative surgery for the chemotherapy-alone group. This trial was registered in June 2012 with the UMIN Clinical Trials Registry as UMIN000008147 [http://www.umin.ac.jp/ctr/index-j.htm]. In December 2017, the study protocol was amended for reducing sample size. A total of 280 patients will be enrolled over the course of 8.5 years.

scholarly journals Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rui Luo ◽  
Fangfang Zheng ◽  
Haobo Zhang ◽  
Weiquan Zhu ◽  
Penghui He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Natural Orifice ◽  
Specimen Extraction ◽  
Natural Orifice Specimen Extraction ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Robotic Assisted Surgery ◽  
Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

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