scholarly journals Dedicated MRI staging versus surgical staging of peritoneal metastases in colorectal cancer patients considered for CRS-HIPEC; the DISCO randomized multicenter trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. P. Engbersen ◽  
C. J. V. Rijsemus ◽  
J. Nederend ◽  
A. G. J. Aalbers ◽  
I. H. J. T. de Hingh ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Diagnostic Laparoscopy ◽  
Controlled Trial ◽  
Peritoneal Metastases ◽  
Surgical Staging ◽  
Mri Findings ◽  
Mri Staging ◽  
Multicenter Randomized Controlled Trial ◽  
Colorectal Cancer Patients

Abstract Background Selecting patients with peritoneal metastases from colorectal cancer (CRCPM) who might benefit from cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is challenging. Computed tomography generally underestimates the peritoneal tumor load. Diagnostic laparoscopy is often used to determine whether patients are amenable for surgery. Magnetic resonance imaging (MRI) has shown to be accurate in predicting completeness of CRS. The aim of this study is to determine whether MRI can effectively reduce the need for surgical staging. Methods The study is designed as a multicenter randomized controlled trial (RCT) of colorectal cancer patients who are deemed eligible for CRS-HIPEC after conventional CT staging. Patients are randomly assigned to either MRI based staging (arm A) or to standard surgical staging with or without laparoscopy (arm B). In arm A, MRI assessment will determine whether patients are eligible for CRS-HIPEC. In borderline cases, an additional diagnostic laparoscopy is advised. The primary outcome is the number of unnecessary surgical procedures in both arms defined as: all surgeries in patients with definitely inoperable disease (PCI > 24) or explorative surgeries in patients with limited disease (PCI < 15). Secondary outcomes include correlations between surgical findings and MRI findings, cost-effectiveness, and quality of life (QOL) analysis. Conclusion This randomized trial determines whether MRI can effectively replace surgical staging in patients with CRCPM considered for CRS-HIPEC. Trial registration Registered in the clinical trials registry of U.S. National Library of Medicine under NCT04231175.

scholarly journals Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
T. X. Wong ◽  
S. T. Chen ◽  
S. H. Ong ◽  
S. Shyam ◽  
P. Kandasami ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Cancer Patients ◽  
Elective Surgery ◽  
Controlled Trial ◽  
Normal Diet ◽  
Oral Nutrition ◽  
Nutrition Supplement ◽  
Randomised Controlled ◽  
Colorectal Cancer Patients

Abstract Background While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiation for non-severely malnourished patients with cancer. This protocol paper presents the rationale and design of a randomised controlled trial to evaluate the effectiveness of preoperative as well as an extended 90-day postoperative use of ONS on nutritional and clinical outcomes among patients undergoing elective surgery for breast and colorectal cancer. Methods Patients with primary breast and colorectal cancer undergoing elective surgery are recruited from two tertiary hospitals. Eligible patients are assigned into one of the three intervention arms: (i) Group SS will receive ONS in addition to their normal diet up to 14 days preoperatively and postoperatively up to discharge; (ii) Group SS-E will receive ONS in addition to their normal diet up to 14 days preoperatively, postoperatively up to discharge and for an extended 90 days after discharge; and (iii) Group DS will receive ONS in addition to their normal diet postoperatively up to discharge from the hospital. The ONS is a standard formula fortified with lactium to aid in sleep for recovery. The primary endpoints include changes in weight, body mass index (BMI), serum albumin and prealbumin levels, while secondary endpoints are body composition (muscle and fat mass), muscle strength (handgrip strength), energy and protein intake, sleep quality, haemoglobin, inflammatory markers (transferrin, high sensitivity C-reactive protein, interleukin-6), stress marker (saliva cortisol), length of hospital stay and postoperative complication rate. Discussion This trial is expected to provide evidence on whether perioperative supplementation in breast and colorectal cancer patients presenting with high BMI and not severely malnourished but undergoing the stress of surgery would be beneficial in terms of nutritional and clinical outcomes. Trial registration ClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registered

VICTOR: A phase III placebo-controlled trial of rofecoxib in colorectal cancer patients following surgical resection

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 4038-4038 ◽  
Author(s):  
D. J. Kerr ◽  
J. A. Dunn ◽  
M. J. Langman ◽  
J. L. Smith ◽  
R. S. Midgley ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Surgical Resection ◽  
Controlled Trial ◽  
Phase Iii ◽  
Colorectal Cancer Patients

scholarly journals The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in colorectal cancer patients: study protocol for a pilot single-blinded, randomized sham-controlled trial

2019 ◽  
Author(s):  
Kaiyin Chan ◽  
Louisa Lui ◽  
Kaling Yu ◽  
Kwongwai Lau ◽  
Manchi Lai ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Hong Kong ◽  
Peripheral Neuropathy ◽  
Chinese Medicine ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Efficacy And Safety ◽  
Colorectal Cancer Patients

Abstract Background: Colorectal cancer is the most common cancer in Hong Kong. Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese Medicine Practice. This pilot study aims to examine the efficacy and safety of acupuncture for alleviating CIPN in colorectal cancer patients in Hong Kong. Methods/Design: This is a pilot single-blinded, randomized, sham-controlled trial. Eighty-four eligible patients, who are Hong Kong Chinese aged ≥18 years diagnosed with colorectal cancer and undergoing oxaliplatin-based chemotherapy, will be randomized in a ratio of 1:1 to electro-acupuncture group and sham-controlled group. During a 12-week treatment period, patients in electro-acupuncture group will undergo electro-acupuncture once a week from the first cycle of chemotherapy, patients in control group will receive sham-acupuncture, and the patients in both groups will be followed up for twelve weeks. The primary outcome measure is the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire. The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, quality of life questionnaire-C30 of European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ). Discussion: The study will compare electro-acupuncture with sham acupuncture to explore the feasibility for electro-acupuncture in improving symptoms caused by chemotherapy-induced peripheral neuropathy.

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