Clinical trial · Interventional
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.
NCT01468389CI-TRIAL-00005754unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Taxanes or Platinum in combination with Capecitabine
- description
- The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- chemotherapy followed by capecitabine alone
- description
- 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.
- interventionNames
- Drug: capecitabine
Primary outcomes (1)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.