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"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy

StatusUnknown
PhaseNot applicable
Started2013-07-05
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 22, 2023 (before its estimated July 30, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2023-11-20
minor
Study Status v7
Trial statusRecruiting→Unknown
Primary completion date2025-07→2025-07-30
Completion date2026-07→2026-08-31
2022-04-26
minor
Study Status v6
Primary completion date2024-07→2025-07
Completion date2025-07→2026-07
2021-03-30
minor
Study Status v5
Primary completion date2020-07→2024-07
Completion date2022-07→2025-07
Start date2013-08→2013-07-05
2019-09-10
minor
Study Status v4
Primary completion date2017-07→2020-07
Completion date2020-07→2022-07
Show 3 earlier versions
2017-04-24
minor
Study Status, Study Design, Outcome Measures v3
PhasePhase 3→Not applicable
Secondary endpointsdetails revised at 1 of 1 entry
2016-04-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2016-04→2013-08
Study sitesdetails revised at 1 of 1 site
2016-04-20
notable
Active, Not Recruiting→Not Yet Recruiting Study Identification, Study Status, Study Design, Arms and Interventions, Contacts/Locations, IPDSharing v1
Trial statusActive, Not Recruiting→Not Yet Recruiting
Start date2013-08→2016-04
Enrollment target574→400
InterventionsD2 versus D3 Lymphadenectomy (Procedure)→D3 Lymphadenectomy (Procedure)
Study title-29 characters
"Phase III Randomized Trial Comparing D2 Versusvs D3 Lymphadenectomy in Patients With Gastric Cancer Following Neoadjuvant Chemotherapy-ELANCe Trial
2014-05-13
minor
Original filing
Stomach cancer is the second most common cause of cancer-related deaths in India. Curative surgery offers the only chance of improving survival in this cancer. In patients whose cancer has not spread to other parts of the body (beyond the stomach and lymph nodes around it), removal of stomach (gastrectomy) with lymph nodes around the stomach and along the major vessels supplying blood to the stomach (D2 lymphadenectomy) is regarded as current standard of care at Tata Memorial Centre. However, the extent of lymphadenectomy is controversial. Some studies have suggested that removing more lymph nodes, even around the major vessels of the abdomen (aorta and inferior vena cava) may not only help to accurately determine the disease spread, but may also confer an additional survival benefit. Removing more lymph nodes around the major vessels may increase the risk of morbidity to the patient. In the last 5-6 years, stomach cancer specialists around the world have resorted to giving half the cycles of chemotherapy to the patient before the surgery (neoadjuvant chemotherapy), and the other half after the surgery in what is called 'perioperative chemotherapy'. This has been shown to lead to more patients surviving to 5 years, than before. The investigators feel that perioperative chemotherapy with D2 lymphadenectomy may constitute the best care for our patients with stomach cancer such that no further removal of lymph nodes beyond is required. However, the investigators have no evidence in literature to support this hypothesis. The investigators have thus designed this trial based on which we propose that there exists no difference between a D2 lymphadenectomy and a D3 lymphadenectomy following neoadjuvant chemotherapy for non-metastatic, locally advanced but resectable gastric cancer. The data will enable the development of clear management guidelines for lymph node dissection in stomach cancer.
Trial Details
NCT Number NCT02139605
Lead Sponsor Tata Memorial Centre
Conditions Gastric Cancer
Enrollment 400 participants
Start Date 2013-07-05
Primary Completion 2025-07-30 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2023-11-22