NCT01468389

Brief Summary

The purpose of this study is to investigate whether Taxanes or Platinum 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
300

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_3 gastric-cancer

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, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

1.2 years

First QC Date

November 4, 2011

Last Update Submit

November 8, 2011

Conditions

Gastric Cancer

Keywords

Gastric Cancercapecitabinemaintenance treatment

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    1 year

Secondary Outcomes (4)

  • Tumor response rate

    1 year

  • disease control rate

    1 year

  • overall survival

    3 year

  • adverse events

    3 year

Study Arms (2)

Taxanes or Platinum in combination with Capecitabine

ACTIVE COMPARATOR

The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.

Drug: Capecitabine

chemotherapy followed by capecitabine alone

EXPERIMENTAL

The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression.

Drug: capecitabine

Interventions

capecitabineDRUG

900-1000mg/m2 bid, days 1-14, every 3 weeks

Taxanes or Platinum in combination with Capecitabine

Eligibility Criteria

Age18 Years - 75 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 oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.
  • Measurable disease according to the RECIST criteria
  • ECOG performance status ≤2
  • Life expectancy of ≥3 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 creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>90,000/mm3, Hb\>8g/dl

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
  • Allergic constitution or allergic history to 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
  • Pre-existing neuropathy\>grade 1
  • Legal incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Xu jianming, M.D.

    The Affiliated Hospital of the Chinese Academy of Military Medical Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu jianming, M.D.

CONTACT

861051128358jmxu2003@yahoo.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
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 9, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

CN(1)