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

Sponsor

Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05813015

Collaborator

(none)

Enrollment

Location

Arm

47.1

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Gastric Adenocarcinoma Chemotherapy Effect	Drug: Docetaxel Drug: Tegafur-Gimeracil-Oteracil	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 28, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DS-S group All patients pathologically confirmed pTNM stage III, will receive 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy till 1 year postoperation.	Drug: Docetaxel Docetaxel 40mg/m2，every 21 days，6 cycles. Drug: Tegafur-Gimeracil-Oteracil S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation. Other Names: S-1

Arm

Intervention/Treatment

Experimental: DS-S group

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

Drug: Docetaxel

Docetaxel 40mg/m2，every 21 days，6 cycles.

Drug: Tegafur-Gimeracil-Oteracil

S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation.

Other Names:

S-1

Outcome Measures

Primary Outcome Measures

Recurrence free survival [3 years]
Recurrence free survival

Secondary Outcome Measures

Overall survival [up to 5 years]
Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University	Hanzhou	Zhejiang	China	310000

Sponsors and Collaborators

Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jian Chen, head of Gastrointestinal department of second affiliated hospital of Zhejiang University, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05813015

Other Study ID Numbers:

ZRWC_GC_C001

First Posted:

Apr 14, 2023

Last Update Posted:

Apr 14, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Docetaxel

Tegafur

Study Results

No Results Posted as of Apr 14, 2023