NCT03399110

Brief Summary

Our study aims to compare the efficacy and safety of 4-month versus 6-month adjuvant chemotherapy with capecitabine and oxaliplatin following D2 gastrectomy in patients with gastric cancer. Hypothesis: In patients with gastric cancer who have undergone D2 gastrectomy, a 4-month regimen of capecitabine and oxaliplatin demonstrates noninferiority to a 6-month regimen in terms of disease-free survival (DFS) and safety.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,024

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline
3mo left

Started Nov 2017

Longer than P75 for phase_3 gastric-cancer

Geographic Reach
1 country

9 active sites

Status
active not 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 Progress98%
Nov 2017Jul 2026

Study Start

First participant enrolled

November 17, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

8.7 years

First QC Date

January 8, 2018

Last Update Submit

January 25, 2026

Conditions

Gastric Cancer

Keywords

Gastric cancer,Adjuvant chemtherapy

Outcome Measures

Primary Outcomes (1)

  • DFS

    Disease-free survival

    3-year

Secondary Outcomes (2)

  • Adverse Events

    6-month

  • OS

    3-year

Study Arms (2)

XELOX for 4 months

EXPERIMENTAL

Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of 5 to 6 cycles, each lasting 3 weeks: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 5 to 6 months or until disease progression.

Drug: OxaliplatinDrug: Capecitabine

XELOX for 6 months

ACTIVE COMPARATOR

Adjuvant chemotherapy with capecitabine and oxaliplatin after surgery consists of eight 3-week cycles: oral capecitabine at 1000 mg/m² twice daily on days 1-14, combined with intravenous oxaliplatin at 130 mg/m² on day 1, administered for 6 months or until disease progression.

Drug: OxaliplatinDrug: Capecitabine

Interventions

OxaliplatinDRUG

Oxaliplatin 130 mg/m2

Also known as: Eloxatin
XELOX for 4 monthsXELOX for 6 months
CapecitabineDRUG

Capecitabine 1000mg/m2

Also known as: Xeloda
XELOX for 4 monthsXELOX for 6 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years.
  • Histologically confirmed primary adenocarcinoma of the stomach, staged as II, IIIA, or IIIB according to pathological findings.
  • R0 resection and D2 gastrectomy performed.
  • No other concurrent malignancies.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • No contraindications to chemotherapy.

You may not qualify if:

  • Receipt of preoperative treatment, including radiation therapy, chemotherapy, or immunotherapy.
  • Patients with stage I, IIIC, or IV gastric cancer.
  • Presence of severe organ diseases, including heart, lung, brain, liver, or other vital organ dysfunction.
  • Known or suspected drug allergies.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Location

The First Affiliated Hospital of University of Science and Technology of China

Hefei, China

Location

Jiangsu Cancer Hospital

Nanjing, China

Location

Changhai Hospital

Shanghai, China

Location

Second Affiliated Hospital (Changzheng Hospital) of Naval Medical University

Shanghai, China

Location

Shanghai East Hospital

Shanghai, China

Location

13940152108@163.Com

Shenyang, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

OxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Dazhi Xu, PHD, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

November 17, 2017

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

July 25, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

CN(9)