A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.

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

Details

• Lead Sponsor: Fudan University
• Collaborators: Affiliated Hospital of Jiangnan University; First Affiliated Hospital of Zhejiang University; Fujian Cancer Hospital; Jiangsu Cancer Institute & Hospital; The First Affiliated Hospital of Xiamen University
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Paclitaxel

Criteria

Inclusion Criteria:

• Joined the study voluntarily and signed informed consent form;

• Age 18-75

• Both genders

• Esophageal squamous cell carcinoma confirmed by pathology

• Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)

• No radiotherapy, chemotherapy or other treatments prior to enrollment

• PS ECOG 0-2

• Life expectancy of more than 3 months

• Hemoglobin（Hb）≥9 g/dL

• WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L

• platelet count (Pt) ≥100x 109/L

• Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN

• Renal function: creatinine < 1.5 x ULN

• No immuno-deficiency

• Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

• Complete esophageal obstruction

• Deep esophageal ulcer

• Esophageal perforation

• Haematemesis

• After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy

• Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years

• Participation in other interventional clinical trials within 30 days

• Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives

• Drug addiction

• Alcoholism or AIDS

• Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior

• Patient who has metastasis such as lung, liver metastasis