Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone as First Line Treatment for Patients With Advanced Adenocarcinoma of Stomach or Esophagogastric Junction

A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01468389

Enrollment

300

Registered

2011-11-09

Start date

2011-11-30

Completion date

2013-06-30

Last updated

2011-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastric Cancer, capecitabine, maintenance treatment

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.

Interventions

DRUGCapecitabine

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

DRUGcapecitabine

Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Having signed informed consent 2. Age≥ 18 years old 3. Histologically confirmed gastric adenocarcinoma 4. Unresectable recurrent or metastatic disease 5. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months 6. Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months. 7. Measurable disease according to the RECIST criteria 8. ECOG performance status ≤2 9. Life expectancy of ≥3 month 10. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks 11. 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

Exclusion criteria

1. Brain metastasis (known or suspected) 2. Previous systemic therapy for metastatic gastric cancer 3. Inability to take oral medication 4. Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy 5. Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry 6. Allergic constitution or allergic history to any investigating agents. 7. 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. 8. Pregnancy or lactation period 9. Any investigational agent within the past 28 days 10. Other previous malignancy within 5 year 11. Pre-existing neuropathy\>grade 1 12. Legal incapacity

Design outcomes

Primary

Measure	Time frame
Progression free survival	1 year

Secondary

Measure	Time frame
Tumor response rate	1 year
disease control rate	1 year
overall survival	3 year
adverse events	3 year

Countries

China

Contacts

Primary ContactXu jianming, M.D.

jmxu2003@yahoo.com861051128358

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026