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

Primary Purpose

Stage III Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paclitaxel and Cisplatin
Paclitaxel and Fluorouracil
Paclitaxel and Carboplatin
Radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, concurrent chemoradiotherapy, paclitaxel, cisplatin, carboplatin, fluorouracil

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Patients fulfilling any of the following criteria are ineligible for this study.

  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

Sites / Locations

  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Paclitaxel and Cisplatin (TP)

Paclitaxel and Fluorouracil (TF)

Paclitaxel and Carboplatin（TC）

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

progression free survival
adverse event

Full Information

First Posted
May 23, 2015
Last Updated
February 8, 2022
Sponsor
Fudan University
Collaborators
Huadong Hospital, Wuxi No. 4 People's Hospital, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital of Xiamen University, Jiangxi Provincial Cancer Hospital, Shanxi Province Cancer Hospital, Gansu Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02459457
Brief Title
A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer
Official Title
A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
February 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Huadong Hospital, Wuxi No. 4 People's Hospital, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital of Xiamen University, Jiangxi Provincial Cancer Hospital, Shanxi Province Cancer Hospital, Gansu Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma, concurrent chemoradiotherapy, paclitaxel, cisplatin, carboplatin, fluorouracil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel and Cisplatin (TP)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Paclitaxel and Fluorouracil (TF)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Paclitaxel and Carboplatin（TC）
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and Cisplatin
Other Intervention Name(s)
TP
Intervention Description
patients get Paclitaxel and Cisplatin according to protocol
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and Fluorouracil
Other Intervention Name(s)
TF
Intervention Description
patients get Paclitaxel and Fluorouracil according to protocol
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and Carboplatin
Other Intervention Name(s)
TC
Intervention Description
patients get Paclitaxel and Carboplatin according to protocol
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
1.8Gy/d, d1-5/week, 34Fx
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
1year, 2 years, 3 years
Title
adverse event
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria To be eligible for this study, patient must fulfill all of the following criteria: Histologically confirmed esophageal squamous cell carcinoma Clinical stages II, III or IVa based on the 6th UICC-TNM classification No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD. Aged 18-75 years Adequate organ functions White blood cell (WBC) ≥3×109⁄L Absolute neutrophil counts (ANC) ≥1.5×109⁄L Hemoglobin (Hb) ≥10g⁄dl Platelet (Plt) ≥100×109⁄L Total bilirubin <1.5 upper limit of normal (ULN) Aspartate transaminase (AST) ≤2.5 ULN Alanine aminotransferase (ALT) ≤2.5 ULN Creatinine ≤1.5 ULN ECOG PS of 0-2 Life expectancy ≥3 months Written informed consent Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study. Esophageal perforation or hematemesis 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) Received thoracic, abdominal or craniocerebral surgery within 30 days Enrolled in other clinical trials within 30 days Unstable angina and/or congestive heart failure requiring hospitalization within 6 months Severe psychiatric disease Pregnancy, lactation or unwillingness to adopt contraception Drug addiction Acquired immune deficiency syndrome (AIDS) based upon current CDC definition Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 1 History of radiotherapy in the planning area Other ineligible conditions according to researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuaile Zhao, MD
Organizational Affiliation
+86 18017312534
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35188552
Citation
Ai D, Ye J, Wei S, Li Y, Luo H, Cao J, Zhu Z, Zhao W, Lin Q, Yang H, Zheng X, Zhou J, Huang G, Li L, Li J, Zhang Z, Zhou G, Gu D, Du M, Mo M, Jia H, Zhang Z, Zhao K. Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220120. doi: 10.1001/jamanetworkopen.2022.0120.
Results Reference
derived
PubMed Identifier
30344165
Citation
Ai D, Chen Y, Liu Q, Zhang J, Deng J, Zhu H, Ren W, Zheng X, Li Y, Wei S, Ye J, Zhou J, Lin Q, Luo H, Cao J, Li J, Huang G, Wu K, Fan M, Yang H, Zhu Z, Zhao W, Li L, Fan J, Badakhshi H, Zhao K. Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2). BMJ Open. 2018 Oct 21;8(10):e020785. doi: 10.1136/bmjopen-2017-020785.
Results Reference
derived

Learn more about this trial

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

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