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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591135
• Other study ID #: ESO-Shanghai1
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: August 2018

Study information

• Verified date: October 2018
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a，TxNxM1a （according to AJCC2002）

Scheme:

Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio.

Arm Cisplatin:

Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.

Arm Paclitaxel:

Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Paclitaxel plus 5-fluorouracil
5-?uorouracil 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-?uorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13).
• 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 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.

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Fudan University	Affiliated Hospital of Jiangnan University, First Affiliated Hospital of Zhejiang University, Fudan University Shanghai Cancer Center Minhang Branch, Fujian Cancer Hospital, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-yr overall survival		3 years
Secondary	Disease progression-free survival		3 years
Secondary	Local progression-free survival		3 years
Secondary	Number and grade of Participants with Adverse Events		6 months