Clinical trial · Interventional
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
NCT00915850CI-TRIAL-00003891unknownPhase 1 / Phase 2ClinicalTrials.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)
This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anticancer drug
- description
- docetaxel, cisplatin and 5-FU
- interventionNames
- Drug: DCF
Primary outcomes (1)
- measure
- Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
- timeFrame
- 1 month
Secondary outcomes (5)
- measure
- To determine the recommended phase II dose of docetaxel (Phase I)
- timeFrame
- 1 month
- measure
- To determine the clinical effectiveness in the patients with measurable disease (Phase I)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan * ECOG performance status 0-1 * 20 years and older * Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor * Tissue from tumor must be available * Patients must have measurable disease * Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month * Life expectancy \> 3 months * Laboratory values as follows * 3000/mm3 \< WBC \< 12000/mm3 * 1500/mm3 \< granulocyte count * 8.0 gm/dl \< hemoglobin * Platelet count \> 100000/mm3 * Aspartate transaminase \< 150 IU/L * Alanine transaminase \< 150 IU/L * Creatinine \< 1.5 mg/dl * Able and willing to give valid written informed consent Exclusion Criteria: * Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) * Active or uncontrolled infection * Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week * Clinically significant heart disease * Patients with a history of myocardial infarction within the previous three months * Patients with uncontrolled diabetes mellitus or hypertension * Presence of clinically apparent central nervous system metastases * Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study * Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (0)
Data not yet available
No reference posted for this study.