XELOX With Capecitabine Maintenance or XELOX in Elderly M... | NCT01798251

NCT01798251

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

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XELOX-X	Experimental	XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance. X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance.	Drug: Oxaliplatin Drug: Capecitabine
XELOX	Active Comparator	XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.	Drug: Oxaliplatin Drug: Capecitabine

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug	Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks	XELOX XELOX-X

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
overall survival (OS)		from the date of randomization until death from any cause or up to 1 year
Response Rate (RR)		evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks

Other Outcomes

Measure	Description	Time Frame
health-related quality of life (HRQOL)		evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
excision repair cross-complementing 1(ERCC1) expression	quantitative real-time reverse transcriptase polymerase chain reaction (PCR) assays were performed to determine ERCC1 mRNA expression in tumor tissue.

Eligibility Module

Eligibility 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.

Name	Role	Phone	Extension	Email
Yuxian BAI, PhD	Contact	86 451 86298265		bai_yuxian@126.com
Hong SUI, PhD	Contact	86 13936592698		doctorsui2003@126.com

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D000077150	Oxaliplatin
D000069287	Capecitabine