Clinical trial · Interventional
A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma
A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
NCT01591135CI-TRIAL-00035353completedPhase 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)
The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.
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 Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin plus 5-fluorouracil | Drug | — | UNRESOLVED |
| Paclitaxel plus 5-fluorouracil | Drug | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin
- description
- Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles.
- interventionNames
- Drug: Cisplatin plus 5-fluorouracil
- Radiation: Radiation therapy
- type
- EXPERIMENTAL
- label
- Paclitaxel
- description
- Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles.
- interventionNames
- Drug: Paclitaxel plus 5-fluorouracil
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Joined the study voluntarily and signed informed consent form; * Age 18-75 * Both genders * Esophageal squamous cell carcinoma confirmed by pathology * Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002) * No radiotherapy, chemotherapy or other treatments prior to enrollment * PS ECOG 0-2 * Life expectancy of more than 3 months * Hemoglobin(Hb)≥9 g/dL * WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L * platelet count (Pt) ≥100x 109/L * Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN * Renal function: creatinine \< 1.5 x ULN * No immuno-deficiency * Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: * Complete esophageal obstruction * Deep esophageal ulcer * Esophageal perforation * Haematemesis * After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy * Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years * Participation in other interventional clinical trials within 30 days * Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * Drug addiction * Alcoholism or AIDS * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * Patient who has metastasis such as lung, liver metastasis
References
Publications (2)
- DERIVEDChen Y, Ye J, Zhu Z, Zhao W, Zhou J, Wu C, Tang H, Fan M, Li L, Lin Q, Xia Y, Li Y, Li J, Jia H, Lu S, Zhang Z, Zhao K. Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial. J Clin Oncol. 2019 Jul 10;37(20):1695-1703. doi: 10.1200/JCO.18.02122. Epub 2019 Mar 28. PMID 30920880
- DERIVEDChen Y, Zhu Z, Zhao W, Li L, Ye J, Wu C, Tang H, Lin Q, Li J, Xia Y, Li Y, Zhou J, Zhao K. A randomized phase 3 trial comparing paclitaxel plus 5-fluorouracil versus cisplatin plus 5-fluorouracil in Chemoradiotherapy for locally advanced esophageal carcinoma-the ESO-shanghai 1 trial protocol. Radiat Oncol. 2018 Feb 27;13(1):33. doi: 10.1186/s13014-018-0979-0. PMID 29482649