Clinical trial NCT01917552: Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
Official title: Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer(KCSG ST14-05)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, adjuvant, capecitabine, gastric cancer, stage 1b
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Ulsan University Hospital
name: Seoul National University Bundang Hospital
name: Gangnam Severance Hospital
name: Seoul National University Boramae Hospital
name: Ajou University School of Medicine
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hallym University Medical Center
name: Inje University Haeundae Paik Hospital
name: Kyung Hee University Hospital
name: Gachon University Gil Medical Center
name: Kangbuk Samsung Hospital
name: Kyungpook National University Hospital
First posted: 2013-08-06
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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

Primary outcomes:
measure: recurrence-free survival
timeFrame: 8 years
Secondary outcomes:
measure: overall survival
timeFrame: 8 years
measure: Safety profiles
timeFrame: 8years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Min-Hee Ryu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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