Gastric Cancer Clinical Trial
— LELEGAOfficial title:
Limited Versus Extended Lymphadenectomy in High Risk Elderly With Gastric Adenocarcinoma: a Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | ASST Settelaghi - University of Insubria | Varese |
Lead Sponsor | Collaborator |
---|---|
Italian Research Group for Gastric Cancer |
Italy,
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. — View Citation
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 5y-DSS | 5-year Disease-Specific Survival (DSS) | 5 years | |
Secondary | 5y-OS | 5-year Overall Survival (OS) | 5 years | |
Secondary | Post-operative complications | Post-operative complications according to Clavien Dindo classification | 30 days |
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