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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

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