XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 13, 2012
CompletedFirst Posted
Study publicly available on registry
February 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 6, 2013
May 1, 2013
2 years
December 13, 2012
May 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (3)
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
adverse events (AE)
from date of randomization to 28 days after the last chemo dosage
Other Outcomes (3)
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
assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment
K-ras gene type
assess after randomization and before the first treatment
Study Arms (2)
XELOX-X
EXPERIMENTALXELOX: 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.
XELOX
ACTIVE COMPARATORXELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m\^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
Interventions
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The tumor hospital of Harbin medical university
Harbin, Heilongjiang, 150000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuxian BAI, PhD
The tumor hospital of Harbin medical university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 13, 2012
First Posted
February 25, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
May 6, 2013
Record last verified: 2013-05