A Comparison of Laparoscopic With Open Distal Gastrectomy in Advanced Gastric Cancer After Neoadjuvant Chemotherapy
NCT ID: NCT02404753
Last Updated: 2018-09-28
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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UNKNOWN
PHASE2
102 participants
INTERVENTIONAL
2015-04-30
2022-11-25
Brief Summary
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Detailed Description
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The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival, surgical morbidity and mortality.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopic gastrectomy
Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Neoadjuvant Chemotherapy
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 3 courses.
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy with D2 lymph node dissection
Adjuvant Chemotherapy
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 5 courses.
Open gastrectomy
Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.
Neoadjuvant Chemotherapy
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 3 courses.
Open gastrectomy
Open distal gastrectomy with D2 lymph node dissection
Adjuvant Chemotherapy
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 5 courses.
Interventions
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Neoadjuvant Chemotherapy
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 3 courses.
Laparoscopic gastrectomy
Laparoscopic distal gastrectomy with D2 lymph node dissection
Open gastrectomy
Open distal gastrectomy with D2 lymph node dissection
Adjuvant Chemotherapy
XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 5 courses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy. The T and N stages are determined by the method of Habermann et al.
* The gastric tumors are located in the middle to lower third of the stomach, are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
* No bulky lymph node metastasis is detected by abdominal CT.
* No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
* No clinically apparent distant metastasis.
* Karnofsky performance status ≥70%.
* Sufficient oral intake.
* No previous treatment with chemotherapy or radiation therapy for any tumors.
* No previous surgery for the present disease.
* Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses.
White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0\*104/mm3 (5.0\*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
* No need for emergency surgery due to bleeding or perforation of the primary tumor.
* No mechanical obstruction.
* Written informed consent.
Exclusion Criteria
* Past history of surgery for the gastrointestinal tract.
* Body mass index exceeding 30 kg/m2.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Municipal Science & Technology Commission
OTHER
Peking University
OTHER
Responsible Party
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Ziyu Li, MD
Chief Physician,Associate Professor
Principal Investigators
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Ziyu Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Li Z, Shan F, Ying X, Zhang L, Ren H, Li S, Jia Y, Miao R, Xue K, Li Z, Wang Y, Yan C, Zhang Y, Pang F, Ji J. Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for advanced gastric cancer: study protocol for a randomised phase II trial. BMJ Open. 2018 Aug 10;8(8):e021633. doi: 10.1136/bmjopen-2018-021633.
Li Z, Shan F, Wang Y, Li S, Jia Y, Zhang L, Yin D, Ji J. Laparoscopic versus open distal gastrectomy for locally advanced gastric cancer after neoadjuvant chemotherapy: safety and short-term oncologic results. Surg Endosc. 2016 Oct;30(10):4265-71. doi: 10.1007/s00464-015-4739-z. Epub 2016 Jun 10.
Li Z, Shan F, Ying X, Zhang Y, E JY, Wang Y, Ren H, Su X, Ji J. Assessment of Laparoscopic Distal Gastrectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2019 Dec 1;154(12):1093-1101. doi: 10.1001/jamasurg.2019.3473.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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GISCA2015001/LAP
Identifier Type: -
Identifier Source: org_study_id
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