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XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Capecitabine
Sponsored by
Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Elderly Gastric Cancer, Capecitabine Maintenance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The tumor hospital of Harbin medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XELOX-X

XELOX

Arm Description

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.

XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Secondary Outcome Measures

overall survival (OS)
Response Rate (RR)
adverse events (AE)

Full Information

First Posted
December 13, 2012
Last Updated
May 3, 2013
Sponsor
Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01798251
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Elderly Gastric Cancer, Capecitabine Maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XELOX-X
Arm Type
Experimental
Arm Description
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.
Arm Title
XELOX
Arm Type
Active Comparator
Arm Description
XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
L-OHP
Intervention Description
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
XELODA
Intervention Description
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
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 Outcome Measure Information:
Title
overall survival (OS)
Time Frame
from the date of randomization until death from any cause or up to 1 year
Title
Response Rate (RR)
Time Frame
evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
Title
adverse events (AE)
Time Frame
from date of randomization to 28 days after the last chemo dosage
Other Pre-specified Outcome Measures:
Title
health-related quality of life (HRQOL)
Time Frame
evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
Title
excision repair cross-complementing 1(ERCC1) expression
Description
quantitative real-time reverse transcriptase polymerase chain reaction (PCR) assays were performed to determine ERCC1 mRNA expression in tumor tissue.
Time Frame
assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment
Title
K-ras gene type
Description
Genomic Deoxyribonucleic acid (DNA) is extracted from tumor tissue, direct sequencing technique is used to test K-ras gene type(mutation or wild).
Time Frame
assess after randomization and before the first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxian BAI, PhD
Phone
86 451 86298265
Email
bai_yuxian@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong SUI, PhD
Phone
86 13936592698
Email
doctorsui2003@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuxian BAI, PhD
Organizational Affiliation
The tumor hospital of Harbin medical university
Official's Role
Principal Investigator
Facility Information:
Facility Name
The tumor hospital of Harbin medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxian BAI, PhD
Phone
86 451 86298265
Email
bai_yuxian@126.com
First Name & Middle Initial & Last Name & Degree
Hong SUI, PhD
Phone
86 13936592698
Email
doctorsui2003@126.com
First Name & Middle Initial & Last Name & Degree
Yuxian BAI, PhD
First Name & Middle Initial & Last Name & Degree
Hong SUI, PhD

12. IPD Sharing Statement

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XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

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