NCT05728606

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

January 20, 2023

Last Update Submit

February 5, 2023

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Total incidence of postoperative complications

    Postoperative complications are defined as complications occurring within 30 days after surgery, and will be classified according to the Clavien-Dindo classification system

    Postoperative 30 days

Secondary Outcomes (3)

  • Hospital mortality

    Postoperative 30 days

  • R0 resection rate

    The day of surgery

  • Robotic surgical completion rate

    The day of surgery

Study Arms (1)

Robot-assisted D2 distal gastrectomy

EXPERIMENTAL

Robot-assisted D2 distal gastrectomy after 3-Cycle SOX neoadjuvant chemotherapy

Procedure: Robot-assisted D2 distal gastrectomy

Interventions

Robot-assisted D2 distal gastrectomyPROCEDURE

Robot-assisted D2 distal gastrectomy after 3-Cycle SOX neoadjuvant chemotherapy

Robot-assisted D2 distal gastrectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2023

First Posted

February 15, 2023

Study Start

January 20, 2023

Primary Completion

June 20, 2024

Study Completion

June 20, 2024

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

CN(1)