Back to resultsCapecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Stomach cancer, Palliative chemotherapy, Capecitabine, S-1
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.
Sites / Locations
- National Cancer Center
- Hallym University Sacred Heart Hospital
- Kyung Pook National University Hospital
- Yeungnam University Medical Center
- Gacheon Medical School Gil Medical Center
- Asan Medical Center
- Korea Cancer Center Hospital
- Seoul Samsung Medical Center
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
S-1
Capecitabine
Arm Description
Outcomes
Primary Outcome Measures
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD
Response rate is defined as the proportion of patients who showed OR.
Secondary Outcome Measures
Number of Patients With Adverse Events
Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00278863
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Stomach cancer, Palliative chemotherapy, Capecitabine, S-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-1
Arm Type
Active Comparator
Arm Title
Capecitabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Primary Outcome Measure Information:
Title
Response Rate
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD
Response rate is defined as the proportion of patients who showed OR.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Number of Patients With Adverse Events
Description
Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Pyeongchon
State/Province
Gyeonggido
Country
Korea, Republic of
Facility Name
Kyung Pook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Gacheon Medical School Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial
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