Study of Docetaxel or Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Esophageal Cancer

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.

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

Details

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

Criteria

Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T4aN0M0, according to 7th edition of Union for International Cancer Control (UICC) staging system.

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. WHO performance status (PS) of 0-1

7. Signed informed consent document on file

Exclusion Criteria:

1. Patients have received any prior anticancer therapy

2. Patients with advanced inoperable or metastatic esophageal carcinoma

3. Patients with concomitant hemorrhagic disease

4. Patients with other uncontrollable status that cannot tolerate surgery

5. Pregnant or breast feeding

6. Patients cannot signed the informed consent document because of psychological quality, family and social factors

7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more

8. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer

9. Have a history of diabetes over 10 years and with poorly controlled blood sugar level

10. patients with serious cardiac, respiratory, hepatic, renal, hematologic, immunological disease or cachexy, who cannot tolerate chemoradiotherapy or surgery