Clinical trial NCT01088204: Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer
Official title: A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2010-03-17
Enrollment: 204
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.

Detailed description: To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.

Eligibility criteria: Inclusion Criteria:

* histologically proven primary gastric adenocarcinoma
* T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
* No evidence of other distant metastasis
* not stump carcinoma,(vi) aged 20-80 year old
* performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
* no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
* adequate organ functions defined as indicated below:

  * WBC 3000/mm3, WBC 12 000/mm3
  * Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
  * Plt 100 000/mm3
  * AST 100 IU/l
  * ALT 100 IU/l
  * T.Bil 2.0 mg/dl
  * written informed consent

Exclusion Criteria:

* active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
* pregnant or breast-feeding women
* severe mental disorder
* systemic administration of corticosteroids
* unstable angina or myocardial infarction within 6 months of the trial
* unstable hypertension
* severe respiratory disease requiring continuous oxygen therapy
* previous upper abdominal surgery except laparoscopic cholecystectomy

Primary outcomes:
measure: noncompliance rate
timeFrame: postoperative 1 week
Secondary outcomes:
measure: Postoperative surgical complications
timeFrame: postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months
measure: operating time
timeFrame: operation day
measure: time to first flatus
timeFrame: postoperative 1 week
measure: number of retrieved lymph nodes
timeFrame: postoperative 1 week
measure: number of retrieved lymph nodes at each stations
timeFrame: postoperative 1 week
measure: proximal resection margin
timeFrame: postoperative 1 week
measure: distal resection margin,
timeFrame: postoperative 1 week
measure: unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons
timeFrame: postoperative 3 months
measure: 3-year disease free survival
timeFrame: postoperative 3 years
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Chollanam Do
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Jinju
country: Korea, Republic of
facility: Gyengsang National University Hospital
state: Gyeongsangnam -Do
city: Dae Gu
country: Korea, Republic of
facility: Kyungpook national university hospital
city: Dae Jeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Daegu
country: Korea, Republic of
facility: Dae Gu Veterans Hospital
city: Pusan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
Study officials:
affiliation: National Cancer Center, Korea
name: Young-Woo Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park YK, Yoon HM, Kim YW, Park JY, Ryu KW, Lee YJ, Jeong O, Yoon KY, Lee JH, Lee SE, Yu W, Jeong SH, Kim T, Kim S, Nam BH; COACT group. Laparoscopy-assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: Results From a Randomized Phase II Multicenter Clinical Trial (COACT 1001). Ann Surg. 2018 Apr;267(4):638-645. doi: 10.1097/SLA.0000000000002168.
citation: Nam BH, Kim YW, Reim D, Eom BW, Yu WS, Park YK, Ryu KW, Lee YJ, Yoon HM, Lee JH, Jeong O, Jeong SH, Lee SE, Lee SH, Yoon KY, Seo KW, Chung HY, Kwon OK, Kim TB, Lee WK, Park SH, Sul JY, Yang DH, Lee JS. Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001). J Gastric Cancer. 2013 Sep;13(3):164-71. doi: 10.5230/jgc.2013.13.3.164. Epub 2013 Sep 30.