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

Primary Purpose

Locally Advanced Gastric Adenocarcinoma, Chemotherapy Effect

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Tegafur-Gimeracil-Oteracil
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gastrointestinal Department of Second Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DS-S group

Arm Description

All patients pathologically confirmed pTNM stage III, will receive 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy till 1 year postoperation.

Outcomes

Primary Outcome Measures

Recurrence free survival
Recurrence free survival

Secondary Outcome Measures

Overall survival
Overall survival

Full Information

First Posted
April 2, 2023
Last Updated
April 2, 2023
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05813015
Brief Title
Study of Comparing of With and Without Sequential Therapy of S-1
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Gastric Adenocarcinoma, Chemotherapy Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DS-S group
Arm Type
Experimental
Arm Description
All patients pathologically confirmed pTNM stage III, will receive 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy till 1 year postoperation.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 40mg/m2,every 21 days,6 cycles.
Intervention Type
Drug
Intervention Name(s)
Tegafur-Gimeracil-Oteracil
Other Intervention Name(s)
S-1
Intervention Description
S-1 40-60mg/m2,p.o, BID, day 1-14, till 1 year postoperation.
Primary Outcome Measure Information:
Title
Recurrence free survival
Description
Recurrence free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Jin
Phone
+86-13605809870
Email
Jinxiaoli@zju.edu.cn
Facility Information:
Facility Name
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoli Jin, Doctor
Phone
86-13605809870
Email
Jinxiaoli@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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