Gastric Cancer
Conditions
Keywords
predictive factor, response, gastric neoplasm, oxaliplatin, docetaxol, capecitabine
Brief summary
Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather part of patients can't get benefit from the treatment. It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.
Detailed description
Patients with MGC will be treated with TX or XELOX regimen. Before treatment, 14 days after treatment and after progression, the blood sample will be collected. Primary tumor blocks will also of collected. These samples will be used to detect predictive factors of the two types first line therapy.
Interventions
DRUGDocetaxol
DRUGOxaliplatin
DRUGCapecitabine
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months * Patient must have at least one measurable lesions (RECIST 1.1) * 18 Years to 75 years * Written informed consent obtained * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patients must have adequate organ and marrow function as defined below: * neutrophilicgranulocyte greater than/equal to 1,500/mm3; * platelets greater than/equal to 90,000/ mm3; * hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level); * total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN); * Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN * serum creatinine less than/equal to 1.5 x IULN.
Exclusion criteria
* Active clinically serious infections (\> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events) * Symptomatic metastatic brain or meningeal tumors * History of organ allograft * Patients undergoing renal dialysis * chronic inflammatory bowel disease; ileus; genetic fructose intolerance * Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months * Receive previously radiotherapy in measurable regions * Pregnancy or lactating status * Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma * Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months * Acute or subacute intestinal occlusion or history of the inflammatory bowel disease * Any factors that influence the usage of oral administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response | 6 weeks | RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) will be used to evaluate the response of each patient every 6 weeks. The main purpose of this study is to search for the biomarkers which will predict the response of patients with MGC received TX or XELOX regimen as first line therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival (PFS) | From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months) | PFS is defined as from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| overall survival(OS) | from the date of randomization until the date of death from any cause, assessed up to 60 months | OS is defined as from the date of randomization until the date of death from any cause, assessed up to 60 months |
Countries
China
Contacts
Primary Contactxiaodong Zhu, M.D
Outcome results
None listed