NCT02139605

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

Recruiting now NA Last updated 22 November 2023

What this trial tests

NA trial testing D3 Lymphadenectomy in Gastric Cancer in 400 participants. Currently enrolling.

Timeline

5 July 2013

Primary endpoint
30 July 2025

31 August 2026

Quick facts

Lead sponsor	Tata Memorial Centre
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	400
Start date	5 July 2013
Primary completion	30 July 2025
Estimated completion	31 August 2026
Sites	1 location across India

Drugs / interventions tested

• D3 Lymphadenectomy

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

Tata Memorial Centre — full company profile →

Who can join

Adults 18 to 85, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extended Lymphadenectomy for Gastric Cancer in the Neoadjuvant Era: Current Status, Clinical Implications and Contentious Issues.
   Marano L, Carbone L, Poto GE, Restaino V, et al · · 2023 · cited 26× · PMID 36661716 · DOI 10.3390/curroncol30010067
2. Lymph Node Involvement in Advanced Gastric Cancer in the Era of Multimodal Treatment-Oncological and Surgical Perspective.
   Pelc Z, Skórzewska M, Rawicz-Pruszyński K, Polkowski WP. · · 2021 · cited 13× · PMID 34065596 · DOI 10.3390/cancers13102509
3. Optimal lymph node dissection for gastric cancer: a narrative review.
   Nico R, Veziant J, Chau A, Eveno C, et al · · 2024 · cited 6× · PMID 38654357 · DOI 10.1186/s12957-024-03388-4