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Trial Title:
Robot-assisted D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers
NCT ID:
NCT05728606
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Robot-assisted D2 distal gastrectomy
Description:
Robot-assisted D2 distal gastrectomy after 3-Cycle SOX neoadjuvant chemotherapy
Arm group label:
Robot-assisted D2 distal gastrectomy
Summary:
To evaluate the safety of robot-assisted radical gastrectomy with D2 lymph node
dissection in postoperative complications in patients with neoadjuvant chemotherapy for
gastric cancer (cT3-4a, N+, M0).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Age from over 18 to under 75 years; Primary gastric adenocarcinoma (including pap, tub,
muc, sig, and por) confirmed pathologically by endoscopic biopsy; cT3-4a, N-/+, M0
according to the AJCC 8th Cancer Staging Manual; Without peritoneal metastasis (examined
by laparoscopic examination); Radical resection (R0) through distal subtotal gastrectomy
with D2 lymphadenectomy is anticipated; Performance status 0 or 1 (Eastern Cooperative
Oncology Group) ; ASA (American Society of Anesthesiology) score ≤ 3;
Normal hemodynamic indices:
Blood cell count: HB ≥ 90g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L; Liver and renal function:
BIL<1.5 times of the upper limit of normal reference values, ALT and AST<2.5 times of the
upper limit of normal reference values, and Crea≤1 time of upper limits of normal
reference values.
Therapeutic response rating after neoadjuvant chemotherapy is CR, PR, SD, or Therapeutic
response rating after neoadjuvant chemotherapy is PD, tumor is expected to have radical
resection; Subjects are still willing to continue participating in this clinical trial.
Exclusion Criteria:
History of upper abdominal surgery (include endoscopic mucosal resection or endoscopic
submucosal dissection, except for laparoscopic cholecystectomy); History of acute
pancreatitis; Enlarged or bulky regional lymph node (diameter>3cm) by imaging exam;
Patients have received neoadjuvant therapy prior to screen work; History of other
malignant disease within the past five years; History of cerebrovascular accident within
the past six months; History of continuous systematic administration of corticosteroids
within the past month; Scheduled simultaneous surgery for other disease; Emergency
surgery due to complication (bleeding, obstruction or perforation) caused by gastric
cancer; Pyloric obstruction; FEV1<50% of predicted value; Women who are pregnant or
lactating at the time of screening; Severe mental disorder; Participating in other
clinical studies; Refused to sign the informed consent;
Therapeutic response rating after neoadjuvant chemotherapy is PD, involvement of adjacent
structures(T4b), distal metastasis(M1), or enlarged or bulky regional lymph node
(diameter>3cm) by preoperative imaging Patients cannot complete 3 cycles of chemotherapy
due to intolerance; After 3 cycles of neoadjuvant chemotherapy, patients cannot tolerate
surgery due to severe adverse reactions, or ASA score ≥ 4 ; Patients undertake emergency
operation due to tumor bleeding, perforation or obstruction during chemotherapy; After
signing the informed consent, the patient withdraws from this clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fourth Affiliated Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Qun Zhao, doctor
Phone:
13930162111
Email:
zhaoqun516@126.com
Start date:
January 20, 2023
Completion date:
June 20, 2024
Lead sponsor:
Agency:
Hebei Medical University
Agency class:
Other
Source:
Hebei Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05728606
