Clinical trial NCT01798251: XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
Official title: A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Elderly Gastric Cancer
Capecitabine Maintenance
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 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: overall survival (OS)
timeFrame: from the date of randomization until death from any cause or up to 1 year
measure: Response Rate (RR)
timeFrame: evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
measure: adverse events (AE)
timeFrame: from date of randomization to 28 days after the last chemo dosage
Other outcomes:
measure: health-related quality of life (HRQOL)
timeFrame: evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
measure: excision repair cross-complementing 1(ERCC1) expression
timeFrame: assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment
measure: K-ras gene type
timeFrame: assess after randomization and before the first treatment
Locations:
city: Harbin
country: China
facility: The tumor hospital of Harbin medical university
state: Heilongjiang
Study officials:
affiliation: The tumor hospital of Harbin medical university
name: Yuxian BAI, PhD
role: PRINCIPAL_INVESTIGATOR
References: