Overview

This trial is active, not recruiting.

Condition esophageal squamous cell carcinoma
Treatments paclitaxel plus 5-fluorouracil, cisplatin plus 5-fluorouracil, radiation therapy
Phase phase 3
Sponsor Fudan University
Collaborator Jiangsu Cancer Institute & Hospital
Start date April 2012
End date July 2018
Trial size 436 participants
Trial identifier NCT01591135, ESO-Shanghai1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles.
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 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.
(Experimental)
Patients randomized in Arm B will receive chemoradiation with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy with paclitaxel and 5-fluorouracil for 2 cycles.
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).
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.

Primary Outcomes

Measure
1-yr overall survivals
time frame: 1 year
2-yr overall survival
time frame: 2 years
3-yr overall survival
time frame: 3 years

Secondary Outcomes

Measure
Disease progression-free survival
time frame: 3 years
Local progression-free survival
time frame: 3 years
Number and grade of Participants with Adverse Events
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Principal investigator Kuai Le Zhao, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Fudan University.