Study of Comparing of With and Without Sequential Therapy of S-1

Chemotherapy Effect Clinical Trial

Official title:

Comparison of With and Without Sequential Single Drug Therapy of S-1 After Adjuvant Chemotherapy With Docetaxel Plus S-1 in Stage III Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813015
• Other study ID #: ZRWC_GC_C001
• Status: Recruiting
• Phase: Phase 3
• Start date: January 28, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Zhejiang University
• Contact: Xiaoli Jin
• Phone: +86-13605809870
• Email: Jinxiaoli[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is: • The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy. All patients with locally advanced gastric cancer will received D2 radical surgery, 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy up to 1 year postoperation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• (1) Histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction;
• (2) Radical surgery (D2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage III;
• (3) No significant tumor recurrence or metastasis as assessed by imaging;
• (4) Age 18 years - 75 years;
• (5) ECOG score of 0 or 1;
• (6) Laboratory tests tolerant to chemotherapy;
• (7) Hematological examination: no obvious signs of hematologic diseases, ANC = 1.5 × 10^9/L, platelet count = 80 × 10^9/L, Hb = 90 g/L, WBC = 3.0 × 10^9/L before enrollment, and no bleeding tendency; (8) Biochemical examination: total bilirubin < 1.5 times the upper limit of normal value, AST, ALT < 2.5 times the upper limit of normal value, creatinine < 1.5 times the upper limit of normal value.

Exclusion Criteria:

• (1) Other pathological types of tumors;
• (2) Pregnant or nursing women;
• (3) Those with a history of other malignant neoplastic disease in the last 5 years;
• (4) Those with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, where the investigator determines whether the clinical severity prevents signing an informed consent form or affects the patient's compliance with oral medications;
• (5) Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months;
• (6) Severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc;
• (7) Those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect S-1 absorption;
• (8) Those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator;
• (9) Known to have peripheral nerve disease = NCI-CTC AE grade 1. but with deep tendon reflexes (DTR) only;
• (10) Those requiring immunosuppressive therapy for organ transplantation;
• (11) who have received other chemotherapy regimens
• (12) Those with uncontrolled severe infections, or other serious concomitant diseases;
• (13) Allergic to S-1 or any of the study drug components.

Related Conditions & MeSH terms

• Adenocarcinoma
• Chemotherapy Effect
• Locally Advanced Gastric Adenocarcinoma

Intervention

Drug:
• Docetaxel
Docetaxel 40mg/m2,every 21 days,6 cycles.
• Tegafur-Gimeracil-Oteracil
S-1 40-60mg/m2,p.o, BID, day 1-14, till 1 year postoperation.

Locations

Country	Name	City	State
China	Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival	Recurrence free survival	3 years
Secondary	Overall survival	Overall survival	up to 5 years