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Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer


Phase 2
65 Years
85 Years
Not Enrolling
Both
Gastric Cancer

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Trial Information

Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer


Inclusion Criteria:



- Pathologically proven gastric or gastroesophageal junction adenocarcinoma

- Metastatic or recurrent unresectable disease

- Measurable lesions (according to Response Evaluation Criteria in Solid Tumors
[RECIST])

- Age: 65-85 years old

- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2

- Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet
count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)

- Adequate renal function (serum creatinine≤ 1.5)

- Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal [UNL],
aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)

- No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to
study treatment is allowed with the exception of capecitabine or S-1) Written
informed consent was signed by the patient

Exclusion Criteria:

- Previous palliative chemotherapy

- Known allergy to study drugs

- CNS metastasis

- Significant medical comorbidities

- Active ongoing infection which antibiotic treatment is needed.

- Previous ( within 5 years) history of other malignancy except cured non-malignant
skin cancer and uterine cervical cancer in situ.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Principal Investigator

Yoon-Koo Kang, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AMC0402

NCT ID:

NCT00278863

Start Date:

November 2004

Completion Date:

January 2007

Related Keywords:

  • Gastric Cancer
  • Stomach cancer
  • Palliative chemotherapy
  • Capecitabine
  • S-1
  • Stomach Neoplasms

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