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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paclitaxel plus 5-fluorouracil
Cisplatin plus 5-fluorouracil
Radiation therapy
Radiation therapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal squamous cell carcinoma, chemoradiotherapy

Eligibility Criteria

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

Sites / Locations

  • Fudan University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cisplatin

Paclitaxel

Arm Description

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

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.

Outcomes

Primary Outcome Measures

3-yr overall survival

Secondary Outcome Measures

Disease progression-free survival
Local progression-free survival
Number and grade of Participants with Adverse Events

Full Information

First Posted
April 18, 2012
Last Updated
October 17, 2018
Sponsor
Fudan University
Collaborators
Jiangsu Cancer Institute & Hospital, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Xiamen University, Fujian Cancer Hospital, Affiliated Hospital of Jiangnan University
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1. Study Identification

Unique Protocol Identification Number
NCT01591135
Brief Title
A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Jiangsu Cancer Institute & Hospital, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Xiamen University, Fujian Cancer Hospital, Affiliated Hospital of Jiangnan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
Esophageal squamous cell carcinoma, chemoradiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cisplatin
Arm Type
Active Comparator
Arm Description
Chemoradiotherapy with cisplatin and 5-fluorouracil for 2 cycles followed by adjuvant chemotherapy for 2 cycles.
Arm Title
Paclitaxel
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel plus 5-fluorouracil
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Cisplatin plus 5-fluorouracil
Intervention Description
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).
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
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 Outcome Measure Information:
Title
3-yr overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Disease progression-free survival
Time Frame
3 years
Title
Local progression-free survival
Time Frame
3 years
Title
Number and grade of Participants with Adverse Events
Time Frame
6 months

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuai Le Zhao, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30920880
Citation
Chen Y, Ye J, Zhu Z, Zhao W, Zhou J, Wu C, Tang H, Fan M, Li L, Lin Q, Xia Y, Li Y, Li J, Jia H, Lu S, Zhang Z, Zhao K. Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial. J Clin Oncol. 2019 Jul 10;37(20):1695-1703. doi: 10.1200/JCO.18.02122. Epub 2019 Mar 28.
Results Reference
derived
PubMed Identifier
29482649
Citation
Chen Y, Zhu Z, Zhao W, Li L, Ye J, Wu C, Tang H, Lin Q, Li J, Xia Y, Li Y, Zhou J, Zhao K. A randomized phase 3 trial comparing paclitaxel plus 5-fluorouracil versus cisplatin plus 5-fluorouracil in Chemoradiotherapy for locally advanced esophageal carcinoma-the ESO-shanghai 1 trial protocol. Radiat Oncol. 2018 Feb 27;13(1):33. doi: 10.1186/s13014-018-0979-0.
Results Reference
derived

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

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