NCT04340440

Brief Summary

Gastric carcinoma is the second most common cause of cancer-related deaths and its main treatment modality if potentially curable is surgery but the optimal surgical resection is controversial. The aim of the current study was to assess the outcomes of curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity and mortality, disease recurrence and survival rates.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable gastric-cancer

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

December 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

2.8 years

First QC Date

April 6, 2020

Last Update Submit

April 8, 2020

Conditions

Gastric Cancer

Keywords

Operable gastric cancerD2 vs D1 lymphadenectomySurgical and Oncologic outcomes

Outcome Measures

Primary Outcomes (2)

  • Postoperative morbidity rate

    Frequency of early postoperative complications

    30 days after surgery

  • Operative mortality rate

    Frequency of early postoperative mortality

    Within 30 days after surgery

Secondary Outcomes (4)

  • 2 years Recurrence rate

    2 years after surgery

  • 2 years Cancer specific mortality rate

    2 years after surgery

  • 2 years Disease free survival rate

    2 years after surgery

  • 2 years Overall survival rate

    2 years after surgery

Study Arms (2)

D1 lymphadenectomy

ACTIVE COMPARATOR

Operable gastric cancer was treated by radical gastrectomy and limited D1 lymphadenectomy

Procedure: D1 lymphadenectomy

D2 lymphadenectomy

ACTIVE COMPARATOR

Operable gastric cancer was treated by radical gastrectomy and extended D2 lymphadenectomy

Procedure: D2 lymphadenectomy

Interventions

D1 lymphadenectomyPROCEDURE

Radical gastrectomy with D1 lymphadenectomy

D1 lymphadenectomy
D2 lymphadenectomyPROCEDURE

Radical gastrectomy with D2 lymphadenectomy

D2 lymphadenectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed gastric carcinoma
  • Potentially operable gastric carcinoma without evidence of distant metastasis

You may not qualify if:

  • Complicated gastric cancer (obstructed or perforated)
  • Locally irresectable tumor
  • Previous or coexisting cancer
  • Prior gastric surgery or neoadjuvant chemotherapy
  • Contraindication for major surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.

    PMID: 15082726BACKGROUND

  • Wu CW, Hsiung CA, Lo SS, Hsieh MC, Chen JH, Li AF, Lui WY, Whang-Peng J. Nodal dissection for patients with gastric cancer: a randomised controlled trial. Lancet Oncol. 2006 Apr;7(4):309-15. doi: 10.1016/S1470-2045(06)70623-4.

    PMID: 16574546BACKGROUND

  • Tamura S, Takeno A, Miki H. Lymph node dissection in curative gastrectomy for advanced gastric cancer. Int J Surg Oncol. 2011;2011:748745. doi: 10.1155/2011/748745. Epub 2011 Jun 14.

    PMID: 22312521BACKGROUND

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Randomization by opaque sealed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Professor

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

December 1, 2014

Primary Completion

September 1, 2017

Study Completion

February 1, 2020

Last Updated

April 10, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share