Clinical trial · Interventional
A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer
A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial
NCT02459457CI-TRIAL-00056426completedPhase 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 purpose of this study is to determined the best scheme in paclitaxel and cisplatin,paclitaxel and fluorouracil,paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.
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 |
|---|---|---|---|
| Stage III Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel and Carboplatin | Drug | — | UNRESOLVED |
| Paclitaxel and Cisplatin | Drug | — | UNRESOLVED |
| Paclitaxel and Fluorouracil | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel and Cisplatin (TP)
- description
- Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w\*4
- interventionNames
- Drug: Paclitaxel and Cisplatin
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel and Fluorouracil (TF)
- description
- Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w\*2
- interventionNames
- Drug: Paclitaxel and Fluorouracil
- Radiation: Radiotherapy
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria To be eligible for this study, patient must fulfill all of the following criteria: 1. Histologically confirmed esophageal squamous cell carcinoma 2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification 3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD. 4. Aged 18-75 years 5. Adequate organ functions 1. White blood cell (WBC) ≥3×109⁄L 2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L 3. Hemoglobin (Hb) ≥10g⁄dl 4. Platelet (Plt) ≥100×109⁄L 5. Total bilirubin \<1.5 upper limit of normal (ULN) 6. Aspartate transaminase (AST) ≤2.5 ULN 7. Alanine aminotransferase (ALT) ≤2.5 ULN 8. Creatinine ≤1.5 ULN 6. ECOG PS of 0-2 7. Life expectancy ≥3 months 8. Written informed consent Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study. 1. Esophageal perforation or hematemesis 2. Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months) 3. Received thoracic, abdominal or craniocerebral surgery within 30 days 4. Enrolled in other clinical trials within 30 days 5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months 6. Severe psychiatric disease 7. Pregnancy, lactation or unwillingness to adopt contraception 8. Drug addiction 9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition 10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade \> 1 11. History of radiotherapy in the planning area 12. Other ineligible conditions according to researchers
References
Publications (2)
- DERIVEDAi D, Ye J, Wei S, Li Y, Luo H, Cao J, Zhu Z, Zhao W, Lin Q, Yang H, Zheng X, Zhou J, Huang G, Li L, Li J, Zhang Z, Zhou G, Gu D, Du M, Mo M, Jia H, Zhang Z, Zhao K. Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220120. doi: 10.1001/jamanetworkopen.2022.0120. PMID 35188552
- DERIVEDAi D, Chen Y, Liu Q, Zhang J, Deng J, Zhu H, Ren W, Zheng X, Li Y, Wei S, Ye J, Zhou J, Lin Q, Luo H, Cao J, Li J, Huang G, Wu K, Fan M, Yang H, Zhu Z, Zhao W, Li L, Fan J, Badakhshi H, Zhao K. Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2). BMJ Open. 2018 Oct 21;8(10):e020785. doi: 10.1136/bmjopen-2017-020785. PMID 30344165