Comparing capecitabine treatment to observation in patients with early-stage gastric cancer after surgery
Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer(KCSG ST14-05)
This study is testing if giving capecitabine chemotherapy after surgery can help people with early-stage gastric cancer stay cancer-free longer compared to just monitoring them without treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 870 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul, Songpa-gu) |
| Trial ID | NCT01917552 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial investigates the effectiveness of adjuvant chemotherapy using capecitabine compared to observation alone in patients who have undergone curative resection for stage IB gastric cancer. The study is multi-center and randomized, focusing on patients with additional risk factors for recurrence, such as age over 65, male gender, and specific types of invasion. Participants will be assigned to either receive capecitabine or be monitored without treatment to evaluate the safety and efficacy of the chemotherapy. The trial aims to provide insights into improving outcomes for patients at higher risk of cancer recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-74 with curatively resected stage IB gastric or gastroesophageal junction adenocarcinoma and at least one additional risk factor for recurrence.
Not a fit: Patients who are pregnant, lactating, or have certain health conditions that disqualify them from receiving chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and reduced recurrence in patients with early-stage gastric cancer.
How similar studies have performed: Previous studies have shown promising results with adjuvant chemotherapy in gastric cancer, suggesting that this approach may be beneficial, although the specific use of capecitabine in this context is being further evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, Songpa-gu
- Asan Medical Center — Seoul, Songpa-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Min-Hee Ryu, MD, PhD — Asan Medical Center
- Study coordinator: Min-Hee Ryu, MD, PhD
- Email: miniryu@amc.seoul.kr
- Phone: +82230105935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.