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SuspendedNCT00568529Updated May 26, 2010

Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

A Phase 2 interventional study of Capecitabine and Oxaliplatin in Gastric Cancer, sponsored by Fudan University. Suspended at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-05-26.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Why this study was suspended
There are not enough patients enrolled.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.

Read the detailed description

The result of treatment in relapsed and refractory gastric cancer is still not satisfactory. For the moment, the combination of 5-Fu and cisplatin is regularly used. Capecitabine and Oxaliplatin are new generation drugs of 5-Fu and cisplatin. The current study is to evaluate the efficacy and toxicity of this combination.

02

Conditions studied

  • Gastric Cancer

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Keywords

  • Advanced gastric cancer
  • Response rate
  • Side effects
  • time to progression
  • overall survival
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 30 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 18 and 70 years
  • Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
  • ECOG performance status ≤1
  • Measurable diseases according to the RECIST
  • Relapse or refractory after the first-line chemotherapy
  • Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).

Exclusion criteria

Exclusion Criteria:

  • Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin
  • Have used any of drugs in the regimen in first-line chemotherapy
  • Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection
  • The evidence of CNS metastasis
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Received other chemotherapy regimen after metastasis
  • Participated in other clinical trials.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Combine Chemotherapy

    XELOX(Xeloda and oxaliplatin combination)

    Drug: Capecitabine and Oxaliplatin

Interventions

  • DrugCapecitabine and Oxaliplatin

    Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w

    Also known as: XELOX(Xeloda and oxaliplatin combination)

06

What researchers measure

Primary outcomes

  1. Response Rate

    Time frame: 2-6 months

Secondary outcomes

  1. time to progression and overall survival

    Time frame: 1 year

07

Study locations

1 site
  • Fudan University Cancer Hospital
    Shanghai, Shanghai 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00568529
Lead sponsor
Fudan University
First posted
Dec 6, 2007
Start date
Oct 2007
Primary completion
Jun 2009
Completion
Feb 2010 (estimated)
Last update
May 26, 2010

Study contacts

Jin Li, PhD
principal investigator · Fudan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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