Gastric Cancer, Metastases
Conditions
Keywords
gastric cancer, chemotherapy, irinotecan, docetaxel
Brief summary
To assess the optimal sequence of the palliative chemotherapy regimen (DP --\> FOLFIRI vs FOLFIRI --\> DP) in metastatic gastric cancer patients.
Detailed description
Gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical oncologists due to poor prognosis. A recent phase III trial comparing docetaxel-cisplatin-5-FU (DCF) to the reference arm of cisplatin-5-FU (CF) showed a significant superiority of DCF in terms of survival, time-to-progression, and response rate. However, because DCF regimen was associated with high incidence of toxicities, the regimen has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer patients. Thus, the optimum front-line chemotherapy regimen should be extensively investigated in these patients to improve survival.
Interventions
DRUGDP
D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr Pre & Post medication Dexamethasone 8mg PO D0 Night (X1) D1 immediately upon waking in the morning, 1 hour before infusion Taxotere, Night (X3) D0 NS 1500 mL IV overnight hydration D1 DNK2 1000 mL IV over 2 hours, pre & post hydration (if Mg \<WNL, mix MgSO4 1 amp) 20% Mannitol 70 mL IV full dripping, 30 mins before cisplatin D2-D3 Dexamethasone 8 mg PO bid, D4-D5 Dexamethasone 4 mg PO bid every 3 weeks
DRUGFOLFIRI
FOLFIRI regimen D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed metastatic adenocarcinoma of the stomach 2. Age ≥ 18 3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 4. Life expectancy of at least 3 months 5. Adequate renal, liver, bone marrow functions 6. Adjuvant chemotherapy more than 12 months from the date of study entry 7. Written informed consent
Exclusion criteria
1. Active infection requiring antibiotics 2. Pregnant, lactating women 3. Brain metastasis 4. Systemic illness not appropriate for chemotherapy 5. Radiotherapy within 2 weeks before the study entry 6. Allergy to drugs used in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Second progress-free survival | 2years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, overall survival | 2years |
Countries
South Korea
Outcome results
None listed