NCT03941561

Brief Summary

The study aims to compare the efficacy and safety of S-1 for 9 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer. Hypothesis: For gastric patients after D2 resection, S-1 for 9 months shows non-inferiority to S-1 for 1 year in disease-free survival(DFS), overall survival (OS) and safety.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,006

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline
12mo left

Started Jan 2019

Longer than P75 for phase_3 gastric-cancer

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2019May 2027

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

May 6, 2019

Last Update Submit

May 29, 2019

Conditions

Gastric Cancer

Keywords

Gastric CancerS-1

Outcome Measures

Primary Outcomes (1)

  • DFS

    Disease-free survival

    3-year

Secondary Outcomes (1)

  • OS

    5-year

Other Outcomes (1)

  • Side effects

    1-year

Study Arms (2)

S-1 for 9 months

EXPERIMENTAL

S-1 80-120mg daily for 14 days in 3 weeks for totally 9 months after D2 resection

Drug: S-1 for 9 months

S-1 for 1 year

ACTIVE COMPARATOR

S-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection

Drug: S-1 for 1 year

Interventions

S-1 for 9 monthsDRUG

S-1 for 9 months after D2 resection

Also known as: Tegafur,Gimeracil and Oteracil Porassium Capsules
S-1 for 9 months
S-1 for 1 yearDRUG

S-1 for 1 year after D2 resection

Also known as: Tegafur,Gimeracil and Oteracil Porassium Capsules
S-1 for 1 year

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The lower age limit of research subjects 18 years old and upper age limit of 75 years old.
  • Be proven to be primary adenocarcinoma of gastric cancer and staged II by pathological evidence
  • R0 surgery with lymphadenectomy
  • Without any other malignancies
  • ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
  • No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L, PLT≥100 x 109 /L and HGB≥90g/L).

You may not qualify if:

  • Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
  • Patients with stage I, III and IV.
  • Unavailable for R0 resection and D2 lymph node dissection.
  • Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection.
  • With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension.
  • Any Known or suspected history of drug allergy test.
  • The researchers believe the patient is not able to complete the entire course of the experiment.
  • Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
  • Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Anqing Municipal Hospital

Anqing, China

RECRUITING

Second Affiliated Hospital, School of Medicine

Hangzhou, China

RECRUITING

Anhui Provincial Hospital

Hefei, China

RECRUITING

Jiangxi Provincial Cancer Hospital

Nanchang, China

RECRUITING

Dazhi Xu

Shanghai, China

RECRUITING

First Affiliated Hospital of Wannan Medical College

Wuhu, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)Tegafurgimeracil

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

FluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dazhi Xu, PHD, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dazhi Xu, PHD, MD

CONTACT

(+86) 020-87343737xudzh@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 8, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2022

Study Completion (Estimated)

May 1, 2027

Last Updated

May 31, 2019

Record last verified: 2019-05

Locations

CN(6)