Clinical trial · Interventional
Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
NCT00313872CI-TRIAL-00006044completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the optimal sequence of the palliative chemotherapy regimen (DP --\> FOLFIRI vs FOLFIRI --\> DP) in metastatic gastric cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Metastases | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DP | Drug | — | UNRESOLVED |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFIRI
- interventionNames
- Drug: FOLFIRI
- type
- EXPERIMENTAL
- label
- DP
- description
- D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr, D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr 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
- interventionNames
- Drug: DP
Primary outcomes (1)
- measure
- Second progress-free survival
- timeFrame
- 2years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.