NCT02038621

Brief Summary

To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2014

Typical duration for phase_2

Status
unknown

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

January 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

2.9 years

First QC Date

January 15, 2014

Last Update Submit

January 15, 2014

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (3)

  • overall survival (OS)

    from the date of randomization until death from any cause or up to 1 year

  • adverse events (AE)

    from date of randomization to 28 days after the last chemo dosage

  • health-related quality of life (HRQOL

    evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage

Study Arms (2)

A

EXPERIMENTAL

Capecitabine: 1000mg/m\^2 bid, days 1-14, every 3 weeks until progression/intolerance.

Drug: PaclitaxelDrug: Oxaliplatin and Capecitabine

B

PLACEBO COMPARATOR

Observation until progression

Drug: PaclitaxelDrug: Oxaliplatin and Capecitabine

Interventions

PaclitaxelDRUG
AB
Oxaliplatin and CapecitabineDRUG

Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\\PR\\SD,then randomized into this clinical trial.

AB

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years old
  • male or female
  • Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
  • ECOG performance status score 0-2 ;
  • Expected survival time more than three months ;
  • Adequate hematologic parameters and liver and kidney function ;
  • Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
  • Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
  • Renal : serum creatinine ≤ ULN ;
  • Informed consent of patients or their agents , and signed informed consent.

You may not qualify if:

  • For patients allergic to capecitabine ;
  • Patients with CNS metastases
  • Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
  • Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
  • Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
  • Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
  • The researchers believe that this test is not suitable for those who participate .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PaclitaxelOxaliplatinCapecitabine

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Chengya Zhou, bachelor

CONTACT

86 13980972569yaya713913@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oncology physician

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 16, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

January 16, 2014

Record last verified: 2014-01