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The effect of three-drug versus two-drug perioperative chemotherapy regimens on patient-reported outcomes and clinical outcomes of patients with locally advanced gastric adenocarcinoma: a prospective cohort study

The effect of three-drug versus two-drug perioperative chemotherapy regimens on patient-reported outcomes and clinical outcomes of patients with locally advanced gastric adenocarcinoma: a prospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073072
Enrollment
Unknown
Registered
2023-06-30
Start date
2023-07-01
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Adenocarcinoma

Interventions

Three-drug perioperative chemotherapy regimens group (FLOT, etc.):None
Two-drug perioperative chemotherapy regimens group (CAPOX, SOX, FOLFOX, FLO, FP, etc.):None

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age > 18 years or older, male or female; 2. Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by pathological histology or cytology; 3. Tumor stage cT2-4bNanyM0; 4. ECOG PS score 0-2; 5. Expected survival >= 12 weeks; 6. Important organ functions meet the following requirements (no use of any blood components, cell growth factors, white blood cell enhancers, platelet enhancers, or anemia correction drugs within 14 days before the first neoadjuvant chemotherapy): (1) Absolute neutrophil count (ANC) >= 1.5*10^9/L; (2) Platelets >= 100*10^9/L; (3) Hemoglobin >= 9g/dL; (4) Serum albumin >= 2.8g/dL; (5) Total bilirubin 60mL/min; (7) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) 50% in echocardiography before treatment; 7. No history of surgical resection; 8. Exclusion of peritoneal metastasis by laparoscopy (if clinically suspected); 9. Patients can understand the purpose of the trial, voluntarily participate and sign the informed consent form, are willing to complete the follow-up according to the protocol requirements, are conscious, and can answer questions correctly; 10. Patients can proficiently use smartphones to complete software download and project transmission feedback by themselves or with the help of relatives.

Exclusion criteria

Exclusion criteria: 1. Presence of distant metastasis (M1) before the trial; 2. BMI = 10% within 2 months before treatment; 3. PS score > 2; 4. Pregnant or lactating women; 5. Presence of chronic gastrointestinal diseases; 6. Unable to receive anti-tumor treatment due to patient refusal or organ dysfunction, complications, etc.; 7. Missing information on past medical history, laboratory tests, treatment, etc.; 8. Patients refuse to provide data or refuse to participate in the study; 9. Other situations that the researchers judge to be inappropriate for participation.

Design outcomes

Primary

MeasureTime frame
Quality of life score;

Secondary

MeasureTime frame
R0 excision rate;Tumor retraction grade;ypTNM;Adverse effects rate;

Countries

China

Contacts

Public ContactWensheng Qiu

The Affiliated Hospital of Qingdao University

wsqiuqd@163.com+86 178 5329 9199

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026