Stage II and III Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma
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).
| Status | Not yet recruiting |
| Enrollment | 80 |
| Est. completion date | |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Yat-sen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall survival rate | 2 years | No | |
| Secondary | Pathologic response rate | Pathologic response rate is defined as tumor regression score | 2 years | No |
| Secondary | Disease-free survival | 2 years | No | |
| Secondary | Incidence of adverse event based on CTCAE 4.0 | Incidence of adverse event in patients during treatment period graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 | 2 years | Yes |