Comparing two types of lymph node removal in stomach cancer surgery
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)
This study is testing if a more extensive lymph node removal during stomach cancer surgery can help patients live longer without causing more complications compared to the standard procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT02139605 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of D2 versus D3 lymphadenectomy in patients with gastric cancer who have undergone neoadjuvant chemotherapy. The study will evaluate whether a more extensive lymphadenectomy (D3) can provide a survival benefit without significantly increasing the risk of complications compared to the standard D2 procedure. Participants will be carefully selected based on specific inclusion and exclusion criteria, ensuring that only those with operable gastric adenocarcinoma and no distant metastases are included. The trial will be conducted at Tata Memorial Centre, a leading cancer treatment facility in India.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically proven gastric adenocarcinoma who have completed at least one cycle of neoadjuvant chemotherapy and have an ECOG performance status of 0-1.
Not a fit: Patients with distant metastases, other concurrent cancers, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for patients with gastric cancer undergoing surgery.
How similar studies have performed: Previous studies comparing D2 and D3 lymphadenectomy have shown some survival advantages, but this trial aims to provide more definitive evidence in the context of modern classifications and neoadjuvant chemotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Mumbai, Maharashtra
- Dr Shailesh Vinayak Shrikhande — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Dr Shailesh V Shrikhande, MBBS MS MD — Tata Memorial Centre
- Study coordinator: Dr Shailesh V Shrikhande, MBBS MS MD
- Email: shailushrikhande@hotmail.com
- Phone: +91 222417 7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.