NCT02395640

Brief Summary

This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
438

participants targeted

Target at P50-P75 for phase_3 gastric-cancer

Timeline
Completed

Started Mar 2015

Typical duration for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed
Last Updated

October 26, 2021

Status Verified

March 1, 2015

Enrollment Period

6 years

First QC Date

March 10, 2015

Last Update Submit

October 18, 2021

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    7 months

Secondary Outcomes (4)

  • overall survival

    10 months

  • overall response rate

    2 months

  • Number of Participants with Adverse Events

    2 months

  • quality of life questionnaire

    2 months

Study Arms (2)

XELOX

EXPERIMENTAL

oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14；

Drug: OxaliplatinDrug: Capecitabine

EOX

ACTIVE COMPARATOR

Epirubicin 50mg/m2 d1； oxaliplatin 130mg/m2 d1； capecitabine 1000mg/m2 Bid po，d1-14；

Drug: EpirubicinDrug: OxaliplatinDrug: Capecitabine

Interventions

EpirubicinDRUG

50mg/m2 ivgtt d1

EOX
OxaliplatinDRUG
Also known as: 130mg/m2 ivgtt d1
EOXXELOX
CapecitabineDRUG

1000mg/m2 po d1-14

Also known as: Xeloda
EOXXELOX

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
  • measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1
  • an Eastern Cooperative Oncology Group performance status of 0 to 2
  • adequate renal, hepatic, and hematologic function

You may not qualify if:

  • previous chemotherapy or radiotherapy (unless in the adjuvant setting)
  • uncontrolled cardiac disease, or other clinically significant, uncontrolled coexisting illness or previous or concurrent cancer
  • accumulated dose of Epirubicin exceeds 300mg/m2
  • HER2 positive and willing to use trastuzumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Zhu XD, Huang MZ, Wang YS, Feng WJ, Chen ZY, He YF, Zhang XW, Liu X, Wang CC, Zhang W, Ying JE, Wu J, Yang L, Qin YR, Luo JF, Zhao XY, Li WH, Zhang Z, Qiu LX, Geng QR, Zou JL, Zhang JY, Zheng H, Song XF, Wu SS, Zhang CY, Gong Z, Liu QQ, Wang XF, Xu Q, Wang Q, Ji JM, Zhao J, Guo WJ. XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX). Cancer Commun (Lond). 2022 Apr;42(4):314-326. doi: 10.1002/cac2.12278. Epub 2022 Feb 25.

    PMID: 35212487DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

EpirubicinOxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCoordination ComplexesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

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
Professor

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 23, 2015

Study Start

March 1, 2015

Primary Completion

February 23, 2021

Study Completion

February 23, 2021

Last Updated

October 26, 2021

Record last verified: 2015-03

Locations

CN(1)