Clinical trial NCT00278863: Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
Official title: Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Stomach cancer
Palliative chemotherapy
Capecitabine
S-1
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2006-01-19
Enrollment: 96
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.


Eligibility criteria: 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.

Primary outcomes:
measure: Response Rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of Patients With Adverse Events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Pyeongchon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Kyung Pook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gacheon Medical School Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Yoon-Koo Kang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: