NCT03290209

Brief Summary

The purpose of this study is to explore the clinical outcomes of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

September 19, 2017

Last Update Submit

February 4, 2020

Conditions

Stomach Neoplasm

Keywords

Stomach NeoplasmElderly PatientsLaparoscopic D1 Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • 3-year disease specific survival rate

    the rate of 3-year disease specific survival

    36 months

Secondary Outcomes (18)

  • 3-year overall survival rate

    36 months

  • 3-year disease free survival rate

    36 months

  • number of retrieved lymph nodes

    1 day

  • number of positive lymph nodes

    1 day

  • intraoperative blood loss

    1 day

  • +13 more secondary outcomes

Study Arms (2)

Laparoscopic D1 Lymphadenectomy

EXPERIMENTAL

Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.

Procedure: Laparoscopic D1 Lymphadenectomy

Laparoscopic D2 Lymphadenectomy

ACTIVE COMPARATOR

Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.

Procedure: Laparoscopic D2 Lymphadenectomy

Interventions

Laparoscopic D1 LymphadenectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.

Laparoscopic D1 Lymphadenectomy
Laparoscopic D2 LymphadenectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.

Laparoscopic D2 Lymphadenectomy

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age over or equal to 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy, including gastric multiple primary carcinoma
  • cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • expected to perform distal, total or proximal gastrectomy to obtain R0 resection sugicall results.
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) class I to III
  • Written informed consent

You may not qualify if:

  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
  • Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
  • History of other malignant disease within the past 5 years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within the past 6 months
  • History of cerebrovascular accident within the past 6 months
  • History of continuous systematic administration of corticosteroids within 1 month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1\<50% of the predicted values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Changming Huang, Professor

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of gastric surgery, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 21, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2023

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

CN(1)