XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
Conditions
Gastric Cancer
Conditions: official terms
Adenocarcinoma - Stomach Neoplasms
Conditions: Keywords
Elderly Gastric Cancer, Capecitabine Maintenance
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Oxaliplatin Type: Drug
Name: Capecitabine Type: Drug
Overall Status
Recruiting
Summary
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.
Detailed Description
To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 65 Years
Gender: Both
Criteria: Inclusion Criteria:

- Ages Eligible for Study: 65 Years or older

- Genders Eligible for Study: Both

- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2

- Histologically confirmed gastric adenocarcinoma(including LAUREN type).

- Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).

- chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.

- Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.

- No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.

- Able to accept oral medication

- Compliance with protocol

Exclusion Criteria:

- Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.

- Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.

- Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.

- clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.

- Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.

- Organ transplantation requires immunosuppressive treatment.

- Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.

- Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.

- Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).

- Allergy to Oxaliplatin or any study medication ingredients.
Location
The tumor hospital of Harbin medical university
Harbin, Heilongjiang, China
Status: Recruiting
Contact: Yuxian BAI, PhD - 86 451 86298265 - bai_yuxian@126.com
Start Date
December 2012
Completion Date
December 2015
Sponsors
Harbin Medical University
Source
Harbin Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page