Comparing shorter vs standard chemotherapy for gastric cancer
A Randomized Phase 3 Clinical Trial Investigating Optimal Duration of Oxaliplatin Administration in Postoperative XELOX (Oxaliplatin + Capecitabine) Adjuvant Chemotherapy for the Patients With Stage II/III Gastric Cancer
This study is testing if a shorter chemotherapy treatment for stomach cancer can work just as well as the standard longer treatment while causing fewer side effects.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 976 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hallym University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Gyeonggi-do) |
| Trial ID | NCT04787354 on ClinicalTrials.gov |
What this trial studies
This study compares the efficacy and safety of a reduced adjuvant XELOX treatment regimen, consisting of 4 cycles of XELOX followed by 4 cycles of capecitabine alone, against the standard 8 cycles of XELOX for patients with curatively resected gastric cancer. The aim is to determine if the shorter treatment duration can maintain effectiveness while reducing side effects, particularly peripheral neuropathy, which significantly impacts patient quality of life. The study involves patients who have undergone curative surgery for stage II or III gastric or gastroesophageal junction adenocarcinoma. Participants will be monitored for treatment outcomes and side effects throughout the study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with stage II or III gastric or gastroesophageal junction adenocarcinoma who have undergone curative surgery.
Not a fit: Patients who are pregnant, breastfeeding, or have significant comorbidities affecting their ability to tolerate chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more tolerable chemotherapy regimen for gastric cancer patients, improving their quality of life and treatment adherence.
How similar studies have performed: While studies have shown success in reducing chemotherapy duration for colorectal cancer, this approach has not been extensively tested in gastric cancer, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2 resection) * Pathologically confirmed stage II, III patients (AJCC 8th edition) * Age 19 years and older * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2 * Adequate marrow function (ANC \> 1,500/uL, Platelet \>100,000/uL, Hb \> 8.0 g/dL, patients with chronic anemia who require intermittent blood transfusions can also participate in the study) * Adequate renal function, with serum creatinine \< 1.5 x upper limit of normal (ULN). * Adequate hepatic function with serum total bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN * Written, informed consent to the study Exclusion Criteria: * Female patients who are pregnant or breast-feeding * Positive pregnancy test at baseline (postmenopausal women should be amenorrhea for at least 12 months to be considered non-fertile) * Sexually active men and women who are not willing to implement contraception during study and until 3 months after discontinuation of study drug * Evidence of metastasis (including cytologically confirmed malignant ascites) * Prior systemic chemotherapy or radiation therapy for stomach cancer * Patients who have not recovered from serious complications of gastrectomy * History of other malignancies within the last 3 years (excluding adequately treated basal cell carcinoma of the skin, in situ cancer of the cervix, non-metastatic thyroid cancer) * A history of clinically significant uncontrolled seizures, central nervous system disorders, or mental disorders, which make it impossible to understand the informed consent or interfere with compliance with oral drug intake * Clinically significant (i.e., active) heart disease: e.g. unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure with NYHA grade II or higher, severe cardiac arrhythmias or acute coronary syndrome in the past 6 months (including myocardial infarction) * Lack of integrity or malabsorption syndrome in the upper gastrointestinal tract, which is likely to affect the absorption of study drug * Serious uncontrolled infection or other serious uncontrolled disease * History of allograft requiring immunosuppression therapy * Received any investigational drug or procedure within 4 weeks prior to randomization * Active viral infection (for hepatitis B carrier, patients can be registered if HBV-DNA titer is less than 20,000 IU/mL, and are allowed to use prophylactic antiviral agents by investigator's choice) * Active HIV infection * Patients with peripheral sensory neuropathy with functional impairment
Where this trial is running
Gyeonggi-do
- Hallym University Medical Center — Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Bum Jun Kim, Dr
- Email: getwisdom1025@gmail.com
- Phone: 82-31-380-3704
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.