Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
18 Years
N/A
Both
Gastric Cancer, Metastases
Trial Information
Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Second progress-free survival
Outcome Time Frame:
2years
Safety Issue:
No
Principal Investigator
Won Ki Kang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Samsung Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
SMC IRB 2005-03-044
NCT ID:
NCT00313872
Start Date:
May 2003
Completion Date:
January 2010
Related Keywords:
- Gastric Cancer
- Metastases
- gastric cancer
- chemotherapy
- irinotecan
- docetaxel
- Stomach Neoplasms
- Neoplasm Metastasis
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