Clinical trial · Interventional
A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma
A Phase II Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma
NCT02915965CI-TRIAL-00024051unknownPhase 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)
The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).
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 II and III Esophageal Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCX | Drug | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCX and surgery
- description
- docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy
- interventionNames
- Drug: DCX
- Procedure: surgery
Primary outcomes (1)
- measure
- overall survival rate
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Pathologic response rate
- timeFrame
- 2 years
- description
- Pathologic response rate is defined as tumor regression score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable. 2. Patients must not have received any prior anticancer therapy. 3. More than 6 months of expected survival. 4. Age ranges from 18 to 70 years. 5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney. 6. Karnofsky performance status (KPS) of 90 or more. 7. Signed informed consent document on file. Exclusion Criteria: 1. Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine. 2. Patients with concomitant hemorrhagic disease. 3. Pregnant or breast feeding. 4. Inability to use gastric conduit after esophagectomy because of a prior surgery. 5. Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more. 6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.