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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Stage III Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel and Cisplatin (TP)

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

Group Type ACTIVE_COMPARATOR

Paclitaxel and Cisplatin

Intervention Type DRUG

patients get Paclitaxel and Cisplatin according to protocol

Radiotherapy

Intervention Type RADIATION

1.8Gy/d, d1-5/week, 34Fx

Paclitaxel and Fluorouracil (TF)

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

Group Type ACTIVE_COMPARATOR

Paclitaxel and Fluorouracil

Intervention Type DRUG

patients get Paclitaxel and Fluorouracil according to protocol

Radiotherapy

Intervention Type RADIATION

1.8Gy/d, d1-5/week, 34Fx

Paclitaxel and Carboplatin（TC）

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

Group Type ACTIVE_COMPARATOR

Paclitaxel and Carboplatin

Intervention Type DRUG

patients get Paclitaxel and Carboplatin according to protocol

Radiotherapy

Intervention Type RADIATION

1.8Gy/d, d1-5/week, 34Fx

Interventions

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Paclitaxel and Cisplatin

patients get Paclitaxel and Cisplatin according to protocol

Intervention Type DRUG

Paclitaxel and Fluorouracil

patients get Paclitaxel and Fluorouracil according to protocol

Intervention Type DRUG

Paclitaxel and Carboplatin

patients get Paclitaxel and Carboplatin according to protocol

Intervention Type DRUG

Radiotherapy

1.8Gy/d, d1-5/week, 34Fx

Intervention Type RADIATION

Other Intervention Names

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TP TF TC

Eligibility Criteria

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Inclusion Criteria

To be eligible for this study, patient must fulfill all of the following criteria:

1. Histologically confirmed esophageal squamous cell carcinoma
2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification
3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
4. Aged 18-75 years
5. Adequate organ functions

1. White blood cell (WBC) ≥3×109⁄L
2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L
3. Hemoglobin (Hb) ≥10g⁄dl
4. Platelet (Plt) ≥100×109⁄L
5. Total bilirubin \<1.5 upper limit of normal (ULN)
6. Aspartate transaminase (AST) ≤2.5 ULN
7. Alanine aminotransferase (ALT) ≤2.5 ULN
8. Creatinine ≤1.5 ULN
6. ECOG PS of 0-2
7. Life expectancy ≥3 months
8. Written informed consent

Exclusion Criteria

1. Esophageal perforation or hematemesis
2. Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
3. Received thoracic, abdominal or craniocerebral surgery within 30 days
4. Enrolled in other clinical trials within 30 days
5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
6. Severe psychiatric disease
7. Pregnancy, lactation or unwillingness to adopt contraception
8. Drug addiction
9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade \> 1
11. History of radiotherapy in the planning area
12. Other ineligible conditions according to researchers

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No