Trial Title:
Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
NCT ID:
NCT01917552
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Capecitabine
Conditions: Keywords:
Gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, adjuvant, capecitabine, gastric cancer, stage 1b
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
capecitabine
Description:
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
Arm group label:
capecitabine
Other name:
Xeloda
Summary:
multi-center, prospective, randomized, open-label phase III
Detailed description:
This is a prospective, randomized, open-label phase III study of adjuvant chemotherapy
after curative resection in patients with pathologic stage IB (by AJCC 6th edition)
gastric cancer with at least one additional risk factor (additional risk factors for
recurrence include age >65 years, male gender, presence of lymphovascular invasion,
presence of perineural invasion). The superiority design will compare the efficacy and
safety profiles of adjuvant capecitabine (Arm A) versus observation alone (Arm B).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Curatively resected gastric or gastroesophageal junction adenocarcinoma
- Pathologic stage IB (by AJCC 6th edition) with at least one additional risk factor
for recurrence (additional risk factors for recurrence include age >65 years, male
gender, presence of lymphovascular invasion, presence of perineural invasion).
- Age: 18 -74years
- ECOG performance status: 0-2
- Adequate bone marrow function (ANC >1,500/uL, Platelets 100,000/uL, and Hb > 8.0
g/dL)
- Adequate renal function (serum creatinine < 1.5 mg/dL)
- Adequate hepatic function (bilirubin < 1.5 mg/dL, ALT and AST < 3 times upper limit
of normal)
- Written informed consent
Exclusion Criteria:
- Pregnant or lactating women.
- Women of childbearing potential with either a positive pregnancy test at baseline.
Postmenopausal women must have been amenorrheic for at least 12 months to be
considered of non-child bearing potential.
- Sexually active males and females (of childbearing potential) unwilling to practice
contraception during the study medication and until 3 months after discontinuation
of the study medication.
- Any evidence of metastatic disease (including presence of tumor cells in the
ascites).
- Previous chemotherapy or radiotherapy for the currently treated gastric cancer.
- No recovery from serious complications of gastrectomy.
- History of another malignancy within the last five years except cured basal cell
carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- History of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the investigator to be clinically significant precluding
informed consent or interfering with compliance for oral drug intake.
- Clinically significant (i.e. active) cardiac disease: e.g. unstable angina,
symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or
greater congestive heart failure or serious cardiac arrhythmia requiring medication
or myocardial infarction within the last 6 months.
- Lack of physical integrity of the upper gastrointestinal tract or those who have
malabsorption syndrome likely to influence absorption of capecitabine, or inability
to take oral medication.
- Serious uncontrolled intercurrent infections or other serious uncontrolled
concomitant disease.
- Organ allografts requiring immunosuppressive therapy.
- Received any investigational drug or agent/procedure, i.e. participation in another
trial within 4 weeks before randomization.
- Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or
chemically related analogues, such as brivudine.
- Positive serologic test for HIV
Gender:
All
Minimum age:
18 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Min-Hee Ryu, MD, PhD
Phone:
+82230105935
Email:
miniryu@amc.seoul.kr
Contact backup:
Last name:
Ryu Min-Hee, MD, PhD
Phone:
82-2-3010-5935
Email:
miniryu@amc.seoul.kr
Investigator:
Last name:
Ryoo Back-Yeol, MD,PhD
Email:
Sub-Investigator
Investigator:
Last name:
Ryu Min-Hee, MD,PhD
Email:
Sub-Investigator
Investigator:
Last name:
Park Sook-Ryun, MD,PhD
Email:
Sub-Investigator
Investigator:
Last name:
Nam Byung-Ho
Email:
Sub-Investigator
Investigator:
Last name:
Yook Jeong-Hwan, MD,PhD
Email:
Sub-Investigator
Investigator:
Last name:
Yoo Moon-Won
Email:
Sub-Investigator
Investigator:
Last name:
Kim Bum-Soo
Email:
Sub-Investigator
Start date:
August 19, 2013
Completion date:
August 1, 2026
Lead sponsor:
Agency:
Asan Medical Center
Agency class:
Other
Collaborator:
Agency:
Ulsan University Hospital
Agency class:
Other
Collaborator:
Agency:
Seoul National University Bundang Hospital
Agency class:
Other
Collaborator:
Agency:
Gangnam Severance Hospital
Agency class:
Other
Collaborator:
Agency:
Seoul National University Boramae Hospital
Agency class:
Other
Collaborator:
Agency:
Ajou University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Agency class:
Other
Collaborator:
Agency:
Hallym University Medical Center
Agency class:
Other
Collaborator:
Agency:
Inje University Haeundae Paik Hospital
Agency class:
Other
Collaborator:
Agency:
Kyung Hee University Hospital
Agency class:
Other
Collaborator:
Agency:
Gachon University Gil Medical Center
Agency class:
Other
Collaborator:
Agency:
Kangbuk Samsung Hospital
Agency class:
Other
Collaborator:
Agency:
Kyungpook National University Hospital
Agency class:
Other
Source:
Asan Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01917552
