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A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach

Phase 2
65 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach

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.

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome 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

Safety Issue:


Principal Investigator

Yuxian BAI, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The tumor hospital of Harbin medical university


China: Ethics Committee

Study ID:




Start Date:

December 2012

Completion Date:

December 2015

Related Keywords:

  • Gastric Cancer
  • Elderly Gastric Cancer
  • Capecitabine Maintenance
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms