Actively Recruiting
Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer at Stage IIIb and IV(KCSG ST15-08): TRIUMPH
Led by Asan Medical Center · Updated on 2024-02-28
286
Participants Needed
1
Research Sites
769 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
S
Seoul National University Bundang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer at Stage IIIb and IV(KCSG ST15-08): TRIUMPH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily provide written informed consent before joining the study
- Newly diagnosed with primary gastric or gastroesophageal junction adenocarcinoma confirmed by tissue examination
- Patients who have undergone radical surgery with wide lymph node removal
- Post-operative cancer stage of IIIB or IV (M0) according to TNM classification
- Randomization must occur within 6 weeks after surgery
You will not qualify if you...
- Age under 20 years or 76 years and older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher
- Previous stomach surgery for cancer
- History of other malignant diseases except adequately treated skin cancer or cervical carcinoma in situ, or other cancers treated over 5 years ago with no recurrence
- Presence of distant metastasis (M1), including specific lymph nodes beyond regional area
- Residual cancer detected after surgery (R1 or R2 resection)
- Prior chemotherapy, radiotherapy, immunotherapy, or other treatments for gastric cancer
- Participation in another clinical trial or use of investigational products within 30 days before consent
- Recent serious heart or brain events within 6 months (e.g., heart attack, severe angina, stroke, serious arrhythmia)
- Uncontrolled seizures, central nervous system or psychological disorders preventing consent or oral medication
- Active uncontrolled infections or sepsis
- Deep vein thrombosis within 4 weeks before consent
- Severe acute or chronic diseases that affect study participation or result interpretation
- Incomplete recovery from surgery
- Difficulty absorbing oral medications due to gastrointestinal conditions or surgeries
- Women of childbearing potential not agreeing to effective birth control during and 6 months after treatment
- Pregnant or breastfeeding women, or positive pregnancy test
- Inadequate bone marrow or organ function as defined by specific blood counts and lab values
- Peripheral neuropathy of grade 2 or higher
- History of allergic reactions to study drugs (Docetaxel, Capecitabine, Oxaliplatin)
- Use of immunosuppressant or prohibited medications
- Receiving anticoagulant therapy with warfarin or similar drugs
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 138-736
Actively Recruiting
Research Team
M
Min-Hee Ryu, M.D.,Ph.D
CONTACT
H
Hyung-Don Kim, M.D.,Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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