"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy
Phase III Randomized Controlled Trial Comparing D2 Versus D3 Lymphadenectomy on Outcomes of Non-metastatic, Resectable, But Locally Advanced, Gastric Cancer Following Neoadjuvant (Perioperative) Chemotherapy (ELANCe Trial)
1 other identifier
interventional
400
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable gastric-cancer
Started Jul 2013
Longer than P75 for not_applicable gastric-cancer
1 active site
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
July 5, 2013
CompletedFirst Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedNovember 22, 2023
November 1, 2023
12.1 years
July 31, 2013
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
primary endpoint:Overall Survival
overall survival will be calculated from randomization to death.
5 year
Secondary Outcomes (1)
Disease-free survival
2 year
Study Arms (2)
D2 Lymphadenectomy
ACTIVE COMPARATORIntervention D3 Lymphadenectomy
D3 Lymphadenectomy
EXPERIMENTALComparator D2 Lymphadenectomy
Interventions
D3 Lymphadenectomy involves surgical removal of lymph nodes from echelon or compartments 1 to 3 in gastric cancer patients
Eligibility Criteria
You may qualify if:
- ECOG performance status of 0 - 1 in patients deemed fit to undergo surgery at the pre-anaesthetic check
- Histologically proven gastric adenocarcinoma
- No evidence of distant metastases, or locally advanced inoperable disease, as evaluated by computed tomography, chest radiography, ultrasonography, and / or laparotomy
- Patient able to provide valid informed consent
- Patient completed at least 1 cycle of neoadjuvant chemotherapy
You may not qualify if:
- Presence of any 1 of the following:
- Previous or concomitant other cancer
- Primary Oesophageal involvement extending to the stomach
- Distant hepatic / extrahepatic disease discovered on laparotomy
- Gross local disease in the porta precluding a curative resection
- Patient did not consent for the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Shailesh Vinayak Shrikhande
Mumbai, Maharashtra, 400012, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Shailesh V Shrikhande, MBBS MS MD
Tata Memorial Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and GI HPB Surgeon
Study Record Dates
First Submitted
July 31, 2013
First Posted
May 15, 2014
Study Start
July 5, 2013
Primary Completion
July 30, 2025
Study Completion (Estimated)
August 31, 2026
Last Updated
November 22, 2023
Record last verified: 2023-11