NCT03051152

Brief Summary

Background: Literature often shows limited and discordant data regarding the prognostic value of age in gastric-cancer patients. Generally, disease-specific survival does not seem to be worse in the elderly when compared with younger patients, and therefore gastrectomy with extended lymphadenectomy for non-early tumors is considered the "standard" surgical therapy for all of operable patients, despite any age- or comorbidity-related limitations. Recent trials reported a survival benefit for extended nodal dissection compared with the more limited method, but some Authors found age (and comorbidities) to be a relevant predictor of postoperative complications, conditioning the safety of the surgical procedure itself. Methods/Design: The LELEGA Trial (Limited versus Extended Lymphadenectomy in high risk Elderly with Gastric Adenocarcinoma) is a randomized, clinical multicenter trial. All patients \>75 years and with Charlson Comorbidity Score \>5 with resectable M0 gastric cancer are eligible for inclusion and randomization. The primary endpoint is 5-year Disease-Specific Survival (DSS). Secondary endpoints include 5-year Overall Survival (OS) and postoperative complications classified according to Clavien-Dindo. Assuming an alpha (two-sided) of 5%, 232 patients per group are necessary to achieve an 80% power to detect a 13% survival difference (from 56% to 69%) between groups. Discussion: LELEGA trial is a prospective, multicenter randomized study to define optimal extent of lymphadenectomy (extended versus limited) in elderly and high-comorbidity gastric cancer patients.

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
500

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable gastric-cancer

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

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

3.8 years

First QC Date

February 9, 2017

Last Update Submit

February 9, 2017

Conditions

Gastric CancerLocally Advanced Malignant NeoplasmPerioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • 5y-DSS

    5-year Disease-Specific Survival (DSS)

    5 years

Secondary Outcomes (2)

  • 5y-OS

    5 years

  • Post-operative complications

    30 days

Study Arms (2)

Elderly with CCS>5 - D1 gastrectomy

EXPERIMENTAL

Patients aged \>75 years with Charlson Comorbidity Score \> 5 undergoing gastrectomy with limited lymphadenectomy

Procedure: D1 gastrectomy

Elderly with CCS>5 - D2 gastrectomy

EXPERIMENTAL

Patients aged \>75 years with Charlson Comorbidity Score \> 5 undergoing gastrectomy with extended lymphadenectomy

Procedure: D2 gastrectomy

Interventions

D1 gastrectomyPROCEDURE

Gastrectomy with limited lymph node dissection

Elderly with CCS>5 - D1 gastrectomy
D2 gastrectomyPROCEDURE

Gastrectomy with extended lymph node dissection

Elderly with CCS>5 - D2 gastrectomy

Eligibility Criteria

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

You may qualify if:

  • Patients aged \>75 years, with CCS \>5, undergoing curative surgery for locally advanced M0 gastric adenocarcinoma. All patients aged \>75 years with a Charlson Comorbidity Score (CCS) \[17\] of at least 5, with an endoscopic and histological diagnosis of gastric adenocarcinoma underwent standard preoperative staging: contrast enhanced computed tomography of chest, abdomen (with gastric distention) and pelvis. Preoperative staging laparoscopy should be performed in order to exclude peritoneal carcinomatosis.
  • Patients with ability to understand the nature or consequences of the trial.
  • Patients with ability to provide written informed consent.

You may not qualify if:

  • Previous surgery of the stomach.
  • Patients with a previous history of cancer (\< 5 year) or presenting with a co-existing cancer.
  • Patients with bulky nodes at the second level stations;
  • Patients requiring multi-organ resection;
  • Patients refusing blood transfusions;
  • Patients recruited for other trial;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Settelaghi - University of Insubria

Varese, Varese, 21100, Italy

Location

Related Publications (5)

  • Rausei S, Ruspi L, Rosa F, Morgagni P, Marrelli D, Cossu A, Cananzi FC, Lomonaco R, Coniglio A, Biondi A, Cipollari C, Graziosi L, Fumagalli U, Casella F, Bertoli P, di Leo A, Alfieri S, Vittimberga G, Roviello F, Orsenigo E, Quagliuolo V, Montemurro S, Baiocchi G, Persiani R, Bencivenga M, Donini A, Rosati R, Sansonetti A, Ansaloni L, Zanoni A, Galli F, Dionigi G; Italian Research Group for Gastric Cancer (IRGGC). Extended lymphadenectomy in elderly and/or highly co-morbid gastric cancer patients: A retrospective multicenter study. Eur J Surg Oncol. 2016 Dec;42(12):1881-1889. doi: 10.1016/j.ejso.2016.05.003. Epub 2016 Jun 1.

    PMID: 27266816BACKGROUND

  • 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

  • Degiuli M, Sasako M, Ponti A, Vendrame A, Tomatis M, Mazza C, Borasi A, Capussotti L, Fronda G, Morino M; Italian Gastric Cancer Study Group. Randomized clinical trial comparing survival after D1 or D2 gastrectomy for gastric cancer. Br J Surg. 2014 Jan;101(2):23-31. doi: 10.1002/bjs.9345.

    PMID: 24375296BACKGROUND

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PMID: 3558716BACKGROUND

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

    PMID: 19638912BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefano Rausei, MD, PhD

    ASST Settelaghi - University of Insubria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Rausei, MD, PhD

CONTACT

stefano.rausei@asst-settelaghi.it

Laura Ruspi, MD

CONTACT

laura.ruspi@libero.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2025

Last Updated

February 13, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations

IT(1)