A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer

Phase 3

Completed

• Conditions: Stage III Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Paclitaxel and Fluorouracil; Drug: Paclitaxel and Carboplatin; Drug: Paclitaxel and Cisplatin; Radiation: Radiotherapy

• Registration Number: NCT02459457
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-23
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-02
• Study Start: 2015-07-01
• Primary Completion: 2020-07-01
• Status Verified: 2022-02
• Study Completion: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel and Fluorouracil (TF)	Paclitaxel and Fluorouracil	Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w\*2
Paclitaxel and Carboplatin（TC）	Paclitaxel and Carboplatin	Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w\*2
Paclitaxel and Cisplatin (TP)	Radiotherapy	Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w\*4
Paclitaxel and Fluorouracil (TF)	Radiotherapy	Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w\*2
Paclitaxel and Carboplatin（TC）	Radiotherapy	Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w\*2
Paclitaxel and Cisplatin (TP)	Paclitaxel and Cisplatin	Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w\*4

Primary Outcome Measures

Name	Time	Method
overall survival	3 years

Secondary Outcome Measures

Name	Time	Method
progression free survival	1year, 2 years, 3 years
adverse event	3 years

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China