Locally Advanced Gastric CancerNCT06277453
Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy
An observational study of Locally Advanced Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Locally Advanced Gastric Cancer
- What is being tested?
- surgery
- How many people
- 219 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with node-negative gastric cancer following neoadjuvant chemotherapy
Who may be able to join
- (1) preoperative neoadjuvant chemotherapy; (2) primary gastric adenocarcinoma, diagnosed by gastroscopic pathology findings before neoadjuvant chemotherapy in complete pathological remission (pCR) cases or via postoperative pathology findings in all other instances; (3) absence of distant metastases in the liver, lungs, or abdominal cavity, as confirmed by preoperative chest radiography or chest computed tomography (CT), abdominal ultrasonography, abdominal CT, and other imaging; (4) radical gastric cancer surgery (R0) and D2 lymph node dissection; and (5) postoperative pathologic verification of no lymph node metastasis (i.e., lymph node-negative).
Who cannot join
- (1) preoperative radiotherapy or radiochemotherapy, (2) discovery of distant metastases preoperatively or intraoperatively, (3) coexistence of other malignant tumors, (4) residual gastric cancer, and (5) perioperative patient mortality.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastric Surgery， Fujian Medical University Union Hospital
Fuzhou, Fujian
About this study
Official title: Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy: Multicenter Cohort Study
To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy.
Read the detailed description
We analyzed clinicopathological data from patients with lymph node-negative gastric cancer who underwent neoadjuvant chemotherapy at four institutions between 2010 and 2020. The 3-year OS was assessed using landmark analysis. Independent risk factors associated with 3-year OS were identified using a Cox proportional hazards regression model.
- Conditions
- Locally Advanced Gastric Cancer
- Being tested
- surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
radical gastric cancer surgery (R0) and D2 lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| AC ≥5 | Patients with lymph node-negative gastric cancer who received neoadjuvant chemotherapy and underwent at least five cycles of adjuvant chemotherapy (AC ≥5) after surgery Receives: Other: surgery | |
| AC <5 | Patients with lymph node-negative gastric cancer who received neoadjuvant chemotherapy and underwent at less five cycles of adjuvant chemotherapy (AC <5) after surgery Receives: Other: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
3-year overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jan 2023
- Primary completion25 Aug 2023
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-Ming Huang, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277453
- Sponsor's protocol ID
- 2024KY010
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy: Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06277453
- Acronym / sponsor ID
- 2024KY010
- Conditions
- Locally Advanced Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy.
Detailed description
We analyzed clinicopathological data from patients with lymph node-negative gastric cancer who underwent neoadjuvant chemotherapy at four institutions between 2010 and 2020. The 3-year OS was assessed using landmark analysis. Independent risk factors associated with 3-year OS were identified using a Cox proportional hazards regression model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC ≥5 | – | Other: surgeryPatients with lymph node-negative gastric cancer who received neoadjuvant chemotherapy and underwent at least five cycles of adjuvant chemotherapy (AC ≥5) after surgery |
| AC <5 | – | Other: surgeryPatients with lymph node-negative gastric cancer who received neoadjuvant chemotherapy and underwent at less five cycles of adjuvant chemotherapy (AC <5) after surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with node-negative gastric cancer following neoadjuvant chemotherapy
Key inclusion criteria (1 listed)
- (1) preoperative neoadjuvant chemotherapy; (2) primary gastric adenocarcinoma, diagnosed by gastroscopic pathology findings before neoadjuvant chemotherapy in complete pathological remission (pCR) cases or via postoperative pathology findings in all other instances; (3) absence of distant metastases in the liver, lungs, or abdominal cavity, as confirmed by preoperative chest radiography or chest computed tomography (CT), abdominal ultrasonography, abdominal CT, and other imaging; (4) radical gastric cancer surgery (R0) and D2 lymph node dissection; and (5) postoperative pathologic verification of no lymph node metastasis (i.e., lymph node-negative).
Key exclusion criteria (1 listed)
- (1) preoperative radiotherapy or radiochemotherapy, (2) discovery of distant metastases preoperatively or intraoperatively, (3) coexistence of other malignant tumors, (4) residual gastric cancer, and (5) perioperative patient mortality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryradical gastric cancer surgery (R0) and D2 lymph node dissection | Other | AC <5, AC ≥5 |
Primary outcome
3-year overall survival
Time frame: 3 years
3-year overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Ming Huang principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Gastric Cancer, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.