Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— COACT_1001  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01088204
• Other study ID #: NCCCTS-09-448
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 15, 2010
• Last updated: October 5, 2015
• Start date: June 2010
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 204
• Est. completion date: December 2016
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• laparoscopy assisted distal gastrectomy
laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
• open distal gastrectomy
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university hospital	Dae Gu
Korea, Republic of	Konyang University Hospital	Dae Jeon
Korea, Republic of	Dae Gu Veterans Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Chollanam Do
Korea, Republic of	Gyengsang National University Hospital	Jinju	Gyeongsangnam -Do
Korea, Republic of	Kosin University Gospel Hospital	Pusan

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	noncompliance rate	A Case will be designated as "noncompliant" when there are more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping	postoperative 1 week	No
Secondary	Postoperative surgical complications	Major and minor, and short term and long term complications related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification.	postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months	No
Secondary	operating time	From skin incision to wound closure	operation day	No
Secondary	time to first flatus	the day when a patient relieve gastrointestinal gas	postoperative 1 week	No
Secondary	number of retrieved lymph nodes		postoperative 1 week	No
Secondary	number of retrieved lymph nodes at each stations		postoperative 1 week	No
Secondary	proximal resection margin		postoperative 1 week	No
Secondary	distal resection margin,		postoperative 1 week	No
Secondary	unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons	Three randomly assigned laparoscopic gastric cancer surgeons would evaluate the uneditted video and photoes and validate the lymph node dissection according to each stations.When the three surgeons agree that D2 lymph node dissection was performed, it is considered as unanimity.	postoperative 3 months	No
Secondary	3-year disease free survival		postoperative 3 years	No

External Links

•   National Cancer Center web site