Comparing chemotherapy regimens for advanced gastric cancer after surgery
A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) Who Received Radical Resection(KCSG ST15-08)
This study tests if a new combination of chemotherapy drugs can help people with advanced gastric cancer feel better after surgery compared to the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT01935778 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a combination chemotherapy regimen consisting of Docetaxel, Capecitabine, and Oxaliplatin compared to a standard regimen of Capecitabine and Oxaliplatin in patients with advanced gastric cancer who have undergone surgery. It is a multicenter, open-label, randomized Phase III trial that focuses on patients diagnosed with stage IIIB and IV gastric cancer. The study will assess the outcomes of these treatment approaches to determine which provides better post-surgical benefits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 75 who have been newly diagnosed with stage IIIB or IV gastric or gastroesophageal junction adenocarcinoma and have undergone radical surgery.
Not a fit: Patients under 20 or over 75 years old, those with poor performance status, or those with a history of other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with advanced gastric cancer.
How similar studies have performed: Other studies have shown promising results with similar chemotherapy combinations in advanced gastric cancer, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 1. Patients who voluntarily provide written informed consent prior to entering into this study 2. Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically 3. Patients who underwent radical resection with wide lymph node dissection. 4. TNM(tumor/lymph node/metastasis) stage of IIIB or IV on post-operative staging. 5\. Patients who can be randomized within 6 weeks after surgery Exclusion Criteria: * 1\. Aged \< 20 years or ≥ 76 years 2. Eastern Cooperative Oncology Group (ECOG) performance status ≥2 3. Patients who underwent surgery for neoplasm in stomach in the past 4. History of malignant disease The following cases can be included in this study. * Adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ * Other cancer for which more than 5 years have passed since chemotherapy was completed and disease-free status has been maintained for 5 years or more 5. Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node) 6. Residual cancer on post-operative staging (R1 and R2 resection) 7. Patients who received alleviator, adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer 8. Patients who participated in another clinical trial or received another investigational product within 30 days prior to providing informed consent 9. Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment. 10\. Patients with past uncontrolled seizures, central nervous system or psychological disorder which makes it impossible to provide informed consent and is so clinically significant as to interfere with oral medication 11. Uncontrolled active infection or sepsis 12. Deep vein thrombosis within 4 weeks prior to providing informed consent 13. Severe acute or chronic disease which may deteriorate the capability to participate in the study or make it difficult to interpret the study results 14. Not fully recovered from surgery 15. Patients who may have difficulty in absorbing orally administered study drug * Intolerance to oral administration or malabsorption * Lack of physical integrity of upper gastrointestinal tract is not recovered * Absorption disorder for any reason * Ileus * Chronic inflammatory bowel disease * Wide resection of small intestine or other disease limiting drug absorption (e.g., gastric dumping syndrome, features of rapid small bowel transit time, absorption disorder after intestine surgery) 16. Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment 17. Pregnant women or breastfeeding women. Women of childbearing potential whose pregnancy test result is positive 18. Bone marrow and organ function inappropriate for administration of study drug: I. Absolute neutrophil count \< 1.5 x 109/L II. Platelet \< 100 x 109/L III. Hemoglobin ≤ 9 g/dL IV. AST\> 2.5 x ULN, ALT\> 2.5 x ULN V. ALP \> 2.5 x ULN VI. Total bilirubin \> 1.5 x ULN VII. Serum creatinine \> 1.5 x ULN or creatinine clearance ≤ 50 mL/min Creatinine clearance will be calculated by Cockcroft-Gault formula or collection of 24-hour urine, and patients with creatinine clearance of ≤ 50 mL/min will be excluded. 19\. Peripheral neuropathy with clinical symptoms of Grade ≥2 (NCI CTCAE v4.03) 20. History of hypersensitivity to the investigational products (Docetaxel, Capecitabine, and Oxaliplatin). 21\. Patients who are taking immunosuppressant or other prohibited concomitant medication 22. Patients who are receiving anticoagulant therapy with warfarin or other coumarins.
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Min-Hee Ryu, M.D.,Ph.D — Asan Medical Center
- Study coordinator: Min-Hee Ryu, M.D.,Ph.D
- 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.