NCT01331928

Brief Summary

The purpose of this study is to determine whether sequential chemotherapy with capecitabine plus oxaliplatin (Xelox) followed by docetaxel plus capecitabine (TX)in unresectable gastric cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for phase_2 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

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

April 8, 2011

Status Verified

January 1, 2011

Enrollment Period

2 years

First QC Date

February 15, 2011

Last Update Submit

April 7, 2011

Conditions

Gastric Cancer

Keywords

Sequential chemotherapy, gastric cancer

Outcome Measures

Primary Outcomes (1)

  • objective tumor response rate

    Analysis for the objective response rate will be conducted on both the intention-to-treat (ITT) and evaluable data sets. Response will be assessed by Response Evaluation Criteria in Solid Tumor (RECIST 1.1).The analysis will be in descriptive statistics, presented by point estimate and 95% confidence interval for the efficacy variable (Objective tumor response rate)

    2 year

Secondary Outcomes (1)

  • the progression-free survival, overall survival, toxicity profiles

    2 year

Study Arms (1)

Capecitabine, Oxaliplatin, Docetaxel , Gastric cancer

EXPERIMENTAL
Drug: Capecitabine (Xeloda, Roche), Oxaliplatin (Sanofi-Aventis), Docetaxel (Sanofi-Aventis)

Interventions

Capecitabine (Xeloda, Roche), Oxaliplatin (Sanofi-Aventis), Docetaxel (Sanofi-Aventis)DRUG

capecitabine orally 1000 mg/m2 twice daily, day1 to day 10, every 2 weeks plus oxaliplatin 85mg/m2 (2hrs IV infusion)on day1, every 2 weeks for 6 cycles, then shift to docetaxel 30 mg/m2(over 30-minute intravenous infusion) on day 1 and day 8 plus oral capecitabine 825 mg/m2 twice daily on day 1 to 14, every 3 weeks for 4 cycles.

Capecitabine, Oxaliplatin, Docetaxel , Gastric cancer

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed gastric adenocarcinoma.
  • At least one measurable lesion in a non-irradiated area.
  • No prior exposure to systemic chemotherapy for advanced gastric cancer.
  • For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
  • Aged \> 20 years old.
  • ECOG Performance Status \<= 2.
  • Life expectancy greater than 12 weeks.
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate renal function

You may not qualify if:

  • Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy. (Previous radiotherapy is allowable if the last dose was given more than 1 month before the protocol treatment).
  • Major surgery within two weeks prior to entering the study.
  • Patients with CNS metastasis, including clinical suspicion.
  • Patients who are under active or uncontrolled infections.
  • Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
  • Patients with clinically detectable peripheral neuropathy \> 2 on the CTC criteria
  • Patients with concomitant illness that might be aggravated by chemotherapy.
  • Patients who are pregnant or with breast feeding.
  • Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
  • Patients with hypersensitivity to any component of the chemotherapeutic regimen.
  • mental status is not fit for clinical trial
  • can not take study medication orally
  • fertile men and women unless using a reliable and appropriate contraceptive method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei veterans general hospital

Taipei, Taiwan, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

CapecitabineOxaliplatinDocetaxel

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 NucleosidesCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Yee Chao, MD,PHD

    attending physician, cancer center, Taipei Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yee Chao, MD. PHD

CONTACT

+886-2-28712121ychao@vghtpe.gov.tw

Ming-Huang Chen, MD

CONTACT

+886-2-28712121mhchen9@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 15, 2011

First Posted

April 8, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Last Updated

April 8, 2011

Record last verified: 2011-01

Locations

TW(1)