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)

Who is this study for? Patients with non-metastatic, resectable, but locally advanced, gastric cancer following neoadjuvant chemotherapy
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Dr Shailesh Vinayak Shrikhande
RECRUITING
Mumbai
Contact Information
Primary
Dr Shailesh V Shrikhande, MBBS MS MD
shailushrikhande@hotmail.com
+91 222417 7000
Backup
Dr Ashwin Luis Desouza, MBBS MS
ashwindesouza@gmail.com
+91 222417 7000
Time Frame
Start Date: 2013-07-05
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 400
Treatments
Active_comparator: D2 Lymphadenectomy
Intervention D3 Lymphadenectomy
Experimental: D3 Lymphadenectomy
Comparator D2 Lymphadenectomy
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov