Stage II and III Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
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).
Interventions
DRUGDCX
docetaxel, cisplatin and capecitabine
PROCEDUREsurgery
Ivor Lewis Esophagectomy
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival rate | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic response rate | 2 years | Pathologic response rate is defined as tumor regression score |
| Disease-free survival | 2 years | — |
| Incidence of adverse event based on CTCAE 4.0 | 2 years | Incidence of adverse event in patients during treatment period graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 |
Countries
China
Contacts
Primary ContactYanhong Deng, MD PHD
Backup ContactJiayu Ling, MD
Outcome results
None listed