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

Recruiting now · Not applicable

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID

NCT02139605

Run by

Tata Memorial Centre

People needed

400

Starts

2013-07-05

Expected to finish

2026-08-31

Last updated by the study team

2023-11-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Dr Shailesh Vinayak Shrikhande — Mumbai, Maharashtra, India (enrolling)

Full record on ClinicalTrials.gov

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