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

PHASE3CompletedINTERVENTIONAL
Enrollment

436

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Esophageal Squamous Cell Carcinoma
Interventions
DRUG

Paclitaxel plus 5-fluorouracil

5-fluorouracil 300 mg/m2, d1-4, continuous infusion for 96 hours and paclitaxel 50 mg/m2 over 3 hours, d1 (week 1, week 2, week 3, week 4 and week 5); 5-fluorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13).

DRUG

Cisplatin plus 5-fluorouracil

cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).

RADIATION

Radiation therapy

A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

RADIATION

Radiation therapy

A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

Trial Locations (1)

Unknown

Fudan University Cancer Center, Shanghai

All Listed Sponsors
collaborator

Jiangsu Cancer Institute & Hospital

OTHER

collaborator

First Affiliated Hospital of Zhejiang University

OTHER

collaborator

The First Affiliated Hospital of Xiamen University

OTHER

collaborator

Fujian Cancer Hospital

OTHER_GOV

collaborator

Affiliated Hospital of Jiangnan University

OTHER

lead

Fudan University

OTHER

NCT01591135 - A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma | Biotech Hunter | Biotech Hunter