Trial · NCT07912606
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival rate at 2 years | From randomization to 2 years after randomization | Progression-free survival is measured from randomization to the earliest of radiologic or clinical disease progression, postoperative local, regional, or distant recurrence, or death from any cause. Participants without an event are censored at the date of their last adequate disease assessment. The 2-year progression-free survival rate will be estimated by the Kaplan-Meier method. |
| Secondary | Recurrence-free survival rate at 2 years after surgery | From surgery to 2 years after surgery | Among participants who undergo R0 resection, recurrence-free survival is measured from surgery to the earliest of local, regional, or distant recurrence or death from any cause. Participants without an event are censored at the date of their last adequate disease assessment. |
| Secondary | Overall survival | From randomization through 5 years after surgery | Overall survival is measured from randomization to death from any cause. Participants alive at the last follow-up are censored on that date. |
| Secondary | Cumulative incidence of para-aortic lymph node region recurrence | From randomization through 5 years after surgery | Recurrence involving the No. 16a2 or No. 16b1 region is determined by imaging, pathology, or clinical evidence. The cumulative incidence will be estimated with death without para-aortic recurrence treated as a competing event, and recurrence patterns will be summarized. |
| Secondary | R0 resection rate | At definitive postoperative pathological assessment, generally within 30 days after surgery | The percentage of randomized participants with microscopically negative proximal, distal, and applicable circumferential or other resection margins. |
| Secondary | Pathological complete response rate | At definitive postoperative pathological assessment, generally within 30 days after surgery | The percentage of participants with no residual viable tumor in the gastric primary tumor and all evaluated lymph nodes, defined as ypT0N0. |
| Secondary | Number of examined and metastatic regional lymph nodes | At definitive postoperative pathological assessment, generally within 30 days after surgery | Regional lymph nodes will be recorded by station, including the number examined and the number with pathologically confirmed metastasis. |
| Secondary | Pathological positivity rate of No. 16 para-aortic lymph nodes in the experimental arm | At definitive postoperative pathological assessment, generally within 30 days after surgery | Among participants assigned to D2 lymphadenectomy plus para-aortic lymph node dissection who have an evaluable No. 16 specimen, the percentage with at least one pathologically metastatic No. 16 lymph node and the numbers examined and metastatic will be reported. |
| Secondary | Operative time | During the assigned surgery | Operative time in minutes, measured according to the institutional anesthesia and operative record, will be summarized by randomized group. |
| Secondary | Estimated intraoperative blood loss | During the assigned surgery | Estimated blood loss in milliliters, as recorded in the operative and anesthesia records, will be summarized by randomized group. |
| Secondary | Postoperative length of hospital stay | From surgery until discharge, generally within 30 days after surgery | The number of days from surgery to hospital discharge will be summarized by randomized group. |
| Secondary | Rate of Clavien-Dindo grade III or higher postoperative complications | Within 30 days after surgery | The percentage of participants with at least one postoperative complication requiring surgical, endoscopic, or radiologic intervention, intensive care for organ dysfunction, or resulting in death, classified as Clavien-Dindo grade III or higher. |
| Secondary | All-cause postoperative mortality | Within 90 days after surgery | The percentage of participants who die from any cause within 90 days after surgery. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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