Clinical trial · Interventional
Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients
Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin as First-line Treatment for Metastatic Esophageal Squamous Patients: a Prospective Multicenter, Randomized Controlled Clinical Study
NCT03002064CI-TRIAL-00025265unknownPhase 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)
This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus 5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal squamous carcinoma 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 |
|---|---|---|---|
| Chemotherapy Effects | — | UNRESOLVED | — |
| Esophagus Cancer | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DP group
- description
- Docetaxel plus cisplatin. Docetaxel: 60mg per square metre on day 1 and Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- PF group
- description
- Cisplatin plus 5-fluorouracil. Cisplatin: 60mg per square metre on day 1 and 5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles.
- interventionNames
- Drug: Fluorouracil
- Drug: Cisplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors. 2. Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment. Patients were allowed to have palliative radiotherapy 3 months before the enrollment and the target lesions should not be within the radiotherapy region. The last date of adjuvant therapy should be over 6 months before the enrollment. 3. With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 4. With an expected life expectancy of ≥ 3 months. 5. With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale. 6. Without serious system dysfunction and could tolerate chemotherapy. 7. Patients must have normal bone marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×10\^9/L,a neutrophil count of ≥2.0×10\^9/L, , a platelet count of ≥100×10\^9/L. 8. Patients must have normal liver and renal function with a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL. 9. Patients must have normal electrocardiogram results and no history of congestive heart failure. 10. Women of childbearing age should voluntarily take contraceptive measures. Without drug addition 11. Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events. Exclusion Criteria: 1. Allergic to known drug 2. Patients who have received prior treatment including chemotherapy, radiotherapy and surgery for the advanced or metastatic diseases. 3. Receive docetaxel within 6 months as adjuvant or neoadjuvant chemotherapy. 4. Brain metastasis. 5. Without measurable or evaluable disease. 6. With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years. 7. With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure. 8. With neurological or psychiatric abnormalities that affect cognitive. 9. Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)
References
Publications (0)
Data not yet available
No reference posted for this study.