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D1 Versus D2 Lymphadenectomy in High Risk Elderly With Gastric Adenocarcinoma (LELEGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051152
Recruitment Status : Not yet recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Italian Research Group for Gastric Cancer

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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Locally Advanced Malignant Neoplasm Perioperative/Postoperative Complications Procedure: D1 gastrectomy Procedure: D2 gastrectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Limited Versus Extended Lymphadenectomy in High Risk Elderly With Gastric Adenocarcinoma: a Randomized Controlled Trial
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: Elderly with CCS>5 - D1 gastrectomy
Patients aged >75 years with Charlson Comorbidity Score > 5 undergoing gastrectomy with limited lymphadenectomy
Procedure: D1 gastrectomy
Gastrectomy with limited lymph node dissection

Experimental: Elderly with CCS>5 - D2 gastrectomy
Patients aged >75 years with Charlson Comorbidity Score > 5 undergoing gastrectomy with extended lymphadenectomy
Procedure: D2 gastrectomy
Gastrectomy with extended lymph node dissection




Primary Outcome Measures :
  1. 5y-DSS [ Time Frame: 5 years ]
    5-year Disease-Specific Survival (DSS)


Secondary Outcome Measures :
  1. 5y-OS [ Time Frame: 5 years ]
    5-year Overall Survival (OS)

  2. Post-operative complications [ Time Frame: 30 days ]
    Post-operative complications according to Clavien Dindo classification



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Patients operated in an acute setting are excluded to allow for appropriate inclusion and randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051152


Contacts
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Contact: Stefano Rausei, MD, PhD stefano.rausei@asst-settelaghi.it
Contact: Laura Ruspi, MD laura.ruspi@libero.it

Locations
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Italy
ASST Settelaghi - University of Insubria
Varese, Italy, 21100
Contact: Stefano Rausei, MD, PhD       stefano.rausei@asst-settelaghi.it   
Sponsors and Collaborators
Italian Research Group for Gastric Cancer
Investigators
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Principal Investigator: Stefano Rausei, MD, PhD ASST Settelaghi - University of Insubria
Publications:

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Responsible Party: Italian Research Group for Gastric Cancer
ClinicalTrials.gov Identifier: NCT03051152    
Other Study ID Numbers: Varese3
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Postoperative Complications
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes