NCT02902575

Brief Summary

The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

September 11, 2016

Last Update Submit

January 22, 2021

Conditions

Stomach Neoplasms

Keywords

Stomach NeoplasmsLaparoscopyAdvanced Gastric CancerNeoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    The early postoperative complication are defined as the event observed within 30 days after surgery.Postoperative complications were graded according to the Clavien-Dindo classification system

    30 days

Secondary Outcomes (32)

  • Pathological response

    30 days

  • Radiological response

    30 days

  • 3-year disease free survival rate

    36 months

  • 3-year overall survival rate

    36 months

  • 3-year recurrence pattern

    36 months

  • +27 more secondary outcomes

Study Arms (1)

Laparoscopic-assisted Gastrectomy

EXPERIMENTAL

Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group

Procedure: Laparoscopic-assisted gastrectomy with D2 lymphadenectomy

Interventions

Laparoscopic-assisted gastrectomy with D2 lymphadenectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed with curative treated intent.The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy

Laparoscopic-assisted Gastrectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

You may not qualify if:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • History of other malignant disease within past five years
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1\<50% of predicted values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2016

First Posted

September 16, 2016

Study Start

September 1, 2016

Primary Completion

October 31, 2019

Study Completion

November 30, 2019

Last Updated

January 26, 2021

Record last verified: 2021-01