NCT01015339

Brief Summary

The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

November 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

5.8 years

First QC Date

November 17, 2009

Last Update Submit

May 17, 2015

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    3 year

Secondary Outcomes (4)

  • Tumor response rate

    1 year

  • Disease control rate

    1 year

  • Overall survival

    5 year

  • adverse evens

    5 year

Study Arms (2)

Cisplatin plus capecitabine

ACTIVE COMPARATOR
Drug: capecitabineDrug: cisplatin

Paclitaxel plus Capecitabine

EXPERIMENTAL
Drug: PaclitaxelDrug: capecitabine

Interventions

PaclitaxelDRUG

80mg/m2 infusion,d1,d8 every 3 weeks

Paclitaxel plus Capecitabine
capecitabineDRUG

Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks

Paclitaxel plus Capecitabine
cisplatinDRUG

80mg/m2, day 1 of every 3 weeks

Cisplatin plus capecitabine

Eligibility Criteria

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

You may qualify if:

  • Having signed informed consent
  • Age≥ 18 years old
  • Histologically confirmed gastric adenocarcinoma
  • Unresectable recurrent or metastatic disease
  • Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
  • Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
  • Measurable disease according to the RECIST criteria
  • Karnofsky performance status ≥60
  • Life expectancy of ≥2 month
  • No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  • ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  • Serum albumin level ≥3.0g/dL
  • Serum AKP \< 2.5 times ULN
  • Serum creatinine \<ULN, and CCr \< 60ml/min
  • Bilirubin level \< 1.5 ULN
  • +1 more criteria

You may not qualify if:

  • Brain metastasis (known or suspected)
  • Previous systemic therapy for metastatic gastric cancer
  • Inability to take oral medication
  • Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
  • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
  • Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
  • Allergic constitution or allergic history to protium biologic product or any investigating agents.
  • Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
  • Pregnancy or lactation period
  • Any investigational agent within the past 28 days
  • Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Previous adjuvant therapy with capecitabine+platinum,
  • Pre-existing neuropathy\>grade 1
  • Legal incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of GI Oncology, Peking University, School of Oncology

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

PaclitaxelCapecitabineCisplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Lin Shen, MD

    Peking University, School of oncology, Department of GI oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihao Lu, MD

CONTACT

86-10-88196561pppeirain@126.com

Fu Chen, Bachelor

CONTACT

86-10-88196561kimandking@163.com

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
M.D.

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

CN(1)