Using Genetic Polymorphisms to Predict the Efficacy and T... | NCT01558011

NCT01558011

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
100CT202	Other Grant/Funding Number	NRPB

Status Module

Name	Class
Taipei Veterans General Hospital, Taiwan	OTHER_GOV
Tri-Service General Hospital (TSGH)	OTHER
Mackay Memorial Hospital	OTHER
National Cheng-Kung University Hospital

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chemotherapy	Experimental	Chemotherapy: Drug: Capecitabine, Oxaliplatin, Docetaxel Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.	Drug: Capecitabine, Oxaliplatin, Docetaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capecitabine, Oxaliplatin, Docetaxel	Drug	Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial. Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate	Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.	Every 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival	Be calculated as the duration between the first date of randomization and the date of disease recurrence or progression according to RECIST (failed), taking the status of tumor at the treatment has been completed as the reference, or death (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).	Every 6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed gastric adenocarcinoma.
At least one measurable lesion in a non-irradiated area.
No prior exposure to systemic chemotherapy for advanced gastric cancer.
For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
Age > 20 years old.
ECOG Performance Status 2.
Life expectancy greater than 12 weeks.
Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin > 9 g/dl;platelet count 100 x 109/L.
Adequate liver function : ALT & AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin < 2 x ULN
Adequate renal function :Creatinine < 1.5 x ULN.
Patients must be accessible for treatment and follow-up in the participating centers.

Exclusion Criteria:

Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).
Major surgery within two weeks prior to entering the study.
Patients with CNS metastasis, including clinical suspicion.
Patients who are under active or uncontrolled infections.
Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria
Patients with concomitant illness that might be aggravated by chemotherapy.
Patients who are pregnant or with breast feeding.
Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
Patients with hypersensitivity to any component of the chemotherapeutic regimen.
Mental status is not fit for clinical trial
Can not take study medication orally