Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy

Launched by CHONNAM NATIONAL UNIVERSITY HOSPITAL · Dec 7, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating two types of surgery for patients with advanced gastric cancer (a type of stomach cancer) who have already received chemotherapy. The researchers want to compare laparoscopic surgery (a minimally invasive technique using small incisions) with open surgery (a more traditional approach with a larger incision) to see which method allows for better removal of lymph nodes, which are important for determining the extent of cancer. The study will involve 238 patients who have cancer located in the middle or lower part of the stomach and are healthy enough for surgery.

To participate in this trial, patients should be between the ages of 20 and 80 and have a confirmed diagnosis of stomach cancer that is operable. They must also be willing to sign a consent form to take part in the study. Participants will receive four cycles of a specific chemotherapy treatment before and after their surgery. It’s important to note that certain health conditions and recent medical histories may prevent someone from being eligible for the trial. If you or a loved one are considering this trial, it’s a good idea to discuss it further with a healthcare provider to understand the potential benefits and any risks involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who voluntarily expressed their consent to participate in this trial by signing a written 'Subject Consent Form.'
• • 2. Patients whose gastric adenocarcinoma located in the middle or lower part of the stomach is histologically confirmed and deemed possible to perform a radical distal gastrectomy surgery.
• • 3. Patients who come under T2/N(+)M0, T3\~4a/N(- or +) M0 according to the 8th edition of the TNM classification.
• Exclusion Criteria:
• • Methodologies
• • 1. Patients less than 20 years old or older than 80 years old
• • 2. Eastern Cooperative Oncology Group(ECOG) ≥ 2
• • 3. Patients with a surgery experience due to a neoplasm in the stomach.
• • 4. Patients with complications due to gastric cancer (acute hemorrhage, gastric outlet obstruction or perforation)
• • 5. Patients with distant metastases (M1) including distant lymph nodes (Retropancreatic, para-aortic, periportal, retroperitoneal, or mesenteric lymph nodes)
• • 6. Patients without distant metastases but who are, according to a surgeon's judgment, unqualified for radical gastrectomy because of invasions to adjacent organs (T4b).
• • 7. In the case of localized conglomerated metastatic lymph nodes
• • 8. Patients who received surgery or radiation therapy for a primary cancer developed in another organ or those with active/synchronous double cancer in recent 5 years.
• • 9. Patients who participated in another clinical trial or was administered with a different investigational drug in 30 days prior to randomization.
• • 10. Patients who had any of the following in 6 months before the trial recruitment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
• • 11. Patients with a previous experience of uncontrolled seizure, central nervous system or psychological disorders whose conditions are clinically significant to the extent that they are unable to express consent to participate in the trial and oral drug administration is not possible.
• • 12. Patients with uncontrolled active infection or sepsis.
• • 13. Patients who had deep vein thrombosis in recent 4 weeks before the beginning of the trial recruitment.
• • 14. Patients with serious acute or chronic disease that can degrade the patient's ability to participate in the trial or impede the interpretation of the trial results.
• • 15. Pregnant or breast-feeding patients. Fertile female patients who are positive in pregnancy test.
• • Drug Administration for Neoadjuvant Chemotherapy
• 16. Inadequate functions of marrow or organs:
• • I. Absolute Neutrophil Count (ANC) \< 1.5 x 109/L II. Platelet (PLT) \< 100 x 109/L III. Hemoglobin (Hb) ≤ 9 g/dL IV. AST\> 2.5 x ULN, ALT\> 2.5 x ULN V. ALP \> 2.5 x ULN VI. Total Bilirubin (T. Bil) \> 1.5 x ULN VII. Serum creatinine (Cr) \> 1.5 x ULN
• • 17. Patients who have peripheral neuropathy with clinical signs of Grade≥2 (NCI CTCAE v4.03) or with absence of deep tension reflex (DTR).
• • 18. Patients with hypersensitivity history of the investigational drug (5-FU, Oxaliplatin, Docetaxel).
• • 19. Patients who are on treatment with warfarin or coumarin anticoagulants.
• • 20. Patients who are on immunosuppressive therapy.
• • 21. Patients who are receiving co-medication with Cytochrome P450 2A6 inducer, inhibitor, and substrate.