Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus 5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal squamous carcinoma patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

1. Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.

2. Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment. Patients were allowed to have palliative radiotherapy 3 months before the enrollment and the target lesions should not be within the radiotherapy region. The last date of adjuvant therapy should be over 6 months before the enrollment.

3. With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

4. With an expected life expectancy of ≥ 3 months.

5. With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

6. Without serious system dysfunction and could tolerate chemotherapy.

7. Patients must have normal bone marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×10^9/L，a neutrophil count of ≥2.0×10^9/L, , a platelet count of ≥100×10^9/L.

8. Patients must have normal liver and renal function with a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.

9. Patients must have normal electrocardiogram results and no history of congestive heart failure.

10. Women of childbearing age should voluntarily take contraceptive measures. Without drug addition

11. Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

1. Allergic to known drug

2. Patients who have received prior treatment including chemotherapy, radiotherapy and surgery for the advanced or metastatic diseases.

3. Receive docetaxel within 6 months as adjuvant or neoadjuvant chemotherapy.

4. Brain metastasis.

5. Without measurable or evaluable disease.

6. With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.

7. With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.

8. With neurological or psychiatric abnormalities that affect cognitive.

9. Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)