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

Fudan University

Status and phase: Completed; Phase 3

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Paclitaxel plus 5-fluorouracil; Drug: Cisplatin plus 5-fluorouracil; Radiation: Radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01591135

ESO-Shanghai1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 436 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

Cisplatin

Active Comparator group

Description:

Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles.

Treatment:

Drug: Cisplatin plus 5-fluorouracil

Radiation: Radiation therapy

Radiation: Radiation therapy

Paclitaxel

Experimental group

Description:

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.

Treatment:

Radiation: Radiation therapy

Radiation: Radiation therapy

Drug: Paclitaxel plus 5-fluorouracil