Actively Recruiting
"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy
Led by Tata Memorial Centre · Updated on 2023-11-22
400
Participants Needed
1
Research Sites
686 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status of 0 to 1 and fit for surgery
- Confirmed diagnosis of gastric adenocarcinoma by biopsy
- No distant metastases or inoperable locally advanced disease based on scans or surgery
- Able to give informed consent
- Completed at least one cycle of neoadjuvant chemotherapy
You will not qualify if you...
- Having any other previous or current cancer
- Primary oesophageal cancer extending into the stomach
- Distant liver or extrahepatic disease found during surgery
- Large local tumor in the porta area preventing curative surgery
- Declined consent to participate in the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dr Shailesh Vinayak Shrikhande
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
D
Dr Shailesh V Shrikhande, MBBS MS MD
CONTACT
D
Dr Ashwin Luis Desouza, MBBS MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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