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Compares treatment options for Gastric Cancer
Official title Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS
ClinicalTrials.gov ID: NCT01917552
What this study is testing
What is capecitabine?
capecitabine is an investigational medicine, being studied as a potential treatment for gastric cancer.
Also referred to as Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- multi-center, prospective, randomized, open-label phase III
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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...
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study medication and until 3 months...
- 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.
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Songpa-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Songpa-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.