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

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Capecitabine; Drug: capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01468389

AGC001-307PLAH-XJM

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Taxanes or Platinum in combination with Capecitabine

Active Comparator group

Description:

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

Treatment:

Drug: Capecitabine

chemotherapy followed by capecitabine alone

Experimental group

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.

Treatment:

Drug: capecitabine