"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy
NCT ID: NCT02139605
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2013-07-05
2026-08-31
Brief Summary
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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.
Detailed Description
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Of the three published randomised controlled trials(RCT) comparing D2 versus D2+paraaortic nodal dissection (PAND), two of the studies in which the long-term results are available, were carried out in Japan. In both these studies, the patients were not offered chemotherapy until after they developed a recurrence. Another reason is the benefit on survival, albeit modest, in patients undergoing D3 lymphadenectomy that has been noted in the study by Wu et al.
Another important reason for comparing D2 versus D2+PAND, lies in the fact that none of the aforementioned RCTs have been performed after the 1998 revision in the definition of lymph node stations by the Japanese Gastric cancer association. Hence, none of these results can be considered representative of the current classifications.
Duly considering the possible higher morbidity that has been shown with a complete para aortic lymph node dissection, the investigators propose to study a more extensive lymphadenectomy than D2 but without increasing the risk of morbidity in the patient.
D2 lymphadenectomy has been performed at Tata Memorial Centre (TMC), since 2002 with morbidity and mortality rates comparable to world literature It is the standard form of lymphadenectomy in TMC. Hence, the trial will be performed by surgeons experienced in the technique. D3 is performed in some centres in Japan, Italy and Taiwan (where the only randomized controlled trial demonstrated a survival benefit of D3 over D1). Both the procedures are well established and regarded as standards in different parts of the world.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D2 Lymphadenectomy
Intervention D3 Lymphadenectomy
D3 Lymphadenectomy
D3 Lymphadenectomy involves surgical removal of lymph nodes from echelon or compartments 1 to 3 in gastric cancer patients
D3 Lymphadenectomy
Comparator D2 Lymphadenectomy
D3 Lymphadenectomy
D3 Lymphadenectomy involves surgical removal of lymph nodes from echelon or compartments 1 to 3 in gastric cancer patients
Interventions
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D3 Lymphadenectomy
D3 Lymphadenectomy involves surgical removal of lymph nodes from echelon or compartments 1 to 3 in gastric cancer patients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Tata Memorial Centre
OTHER
Responsible Party
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Dr Shailesh Vinayak Shrikhande
Professor and GI HPB Surgeon
Principal Investigators
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Dr Shailesh V Shrikhande, MBBS MS MD
Role: PRINCIPAL_INVESTIGATOR
Tata Memorial Centre
Locations
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Dr Shailesh Vinayak Shrikhande
Mumbai, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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87
Identifier Type: -
Identifier Source: org_study_id