Clinical trial NCT02248519: Laparoscopic Versus Open Gastrectomy for Gastric Cancer
Official title: Laparoscopic Versus Open Gastrectomy for Gastric Cancer, a Multicenter Prospectively Randomized Controlled Trial (LOGICA-trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastric cancer
Gastrectomy
Laparoscopy
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Johnson & Johnson
First posted: 2014-09-25
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take three and five years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.


Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the stomach
* Surgically resectable (cT1-4a, N0-3b, M0) tumor
* Age ≥ 18 years
* European Clinical Oncology Group (ECOG) performance status 0, 1 or 2.
* Written informed consent

Exclusion Criteria:

* Siewert type I esophagogastric junction tumor
* Non-elective surgery
* Previous gastric resection or recurrent gastric cancer
* Pregnancy

Primary outcomes:
measure: Post-operative hospital stay
timeFrame: During admission, an expected average of 2 weeks
Secondary outcomes:
measure: Mortality
timeFrame: 30 days post-operative
measure: Post-operative morbidity
timeFrame: Up to 5 years post-operative
measure: Cost-effectiveness
timeFrame: Up to 5 years post-operative
measure: Quality of Life
timeFrame: Up to 5 years post-operative
measure: Readmissions
timeFrame: Up to 5 years post-operative
measure: Oncologic outcomes (R0-resection rate and lymph node yield)
timeFrame: Pathology report 1-2 weeks after surgery
Other outcomes:
measure: Perioperative blood loss
timeFrame: Post-operative day 1
measure: Operative time
timeFrame: Post-operative day 1
measure: Conversion rate
timeFrame: Post-operative day 1
measure: Survival
timeFrame: Up to 5 years post-operative
measure: VAS-score
timeFrame: Post-operative day 1 and 2
measure: Surgeons ergonomics
timeFrame: Post-operative day 1
measure: Time to return to normal nutritional regime
timeFrame: Up to 5 years post-operative
measure: Time to return to daily activity
timeFrame: Up to 5 years post-operative
Locations:
city: Almelo
country: Netherlands
facility: Zorggroep Twente Almelo
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Apeldoorn
country: Netherlands
facility: Gelre Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Dept. of Surgery, University Medical Center Utrecht
name: Richard van Hillegersberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haverkamp L, Brenkman HJ, Seesing MF, Gisbertz SS, van Berge Henegouwen MI, Luyer MD, Nieuwenhuijzen GA, Wijnhoven BP, van Lanschot JJ, de Steur WO, Hartgrink HH, Stoot JH, Hulsewe KW, Spillenaar Bilgen EJ, Rutter JE, Kouwenhoven EA, van Det MJ, van der Peet DL, Daams F, Draaisma WA, Broeders IA, van Stel HF, Lacle MM, Ruurda JP, van Hillegersberg R; LOGICA study group. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial). BMC Cancer. 2015 Jul 29;15:556. doi: 10.1186/s12885-015-1551-z.
citation: van der Veen A, Brenkman HJF, Seesing MFJ, Haverkamp L, Luyer MDP, Nieuwenhuijzen GAP, Stoot JHMB, Tegels JJW, Wijnhoven BPL, Lagarde SM, de Steur WO, Hartgrink HH, Kouwenhoven EA, Wassenaar EB, Draaisma WA, Gisbertz SS, van der Peet DL, May AM, Ruurda JP, van Hillegersberg R; LOGICA Study Group. Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial. J Clin Oncol. 2021 Mar 20;39(9):978-989. doi: 10.1200/JCO.20.01540. Epub 2021 Jan 6.