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Trial Title:
Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer at Stage IIIb and IV(KCSG ST15-08): TRIUMPH
NCT ID:
NCT01935778
Condition:
Gastric Cancer, Adjuvant Chemotherapy, XO
Conditions: Official terms:
Stomach Neoplasms
Docetaxel
Capecitabine
Oxaliplatin
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:
Docetaxel and capecitabine and oxaliplatin
Description:
Docetaxel 60 mg/m² IV Day 1 Capecitabine 800 mg/m² bid (Day 1-Day 14) Oxaliplatin 100
mg/m² IV Day 1
Arm group label:
Docetaxel and capecitabine and oxaliplatin
Other name:
docetaxel/xeloda/oxliplatin
Intervention type:
Drug
Intervention name:
capecitabine and oxaliplatin
Description:
Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1
Arm group label:
capecitabine and oxaliplatin
Summary:
multicenter, open label, randomaized, phase III
The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC
(advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are
currently accepted as a standard therapy among the AGC patients who were performed
gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB
and IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be
considered as one of the best treatments for IIB and IV(M0) stage AGC patients who were
performed gastrectomy.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
75 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, M.D., Ph.D.
Phone:
+82230105935
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
Start date:
October 2, 2013
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Asan Medical Center
Agency class:
Other
Collaborator:
Agency:
Seoul National University Bundang Hospital
Agency class:
Other
Collaborator:
Agency:
Severance Hospital
Agency class:
Other
Collaborator:
Agency:
Inha University Hospital
Agency class:
Other
Collaborator:
Agency:
Hallym University Medical Center
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/NCT01935778