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

February 8, 2022 updated by: Kuai Le Zhao, MD, Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Drug: Paclitaxel and Cisplatin
patients get Paclitaxel and Cisplatin according to protocol
Other Names:
  • TP
Radiation: Radiotherapy
1.8Gy/d, d1-5/week, 34Fx
ACTIVE_COMPARATOR: 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
Radiation: Radiotherapy
1.8Gy/d, d1-5/week, 34Fx
Drug: Paclitaxel and Fluorouracil
patients get Paclitaxel and Fluorouracil according to protocol
Other Names:
  • TF
ACTIVE_COMPARATOR: 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
Radiation: Radiotherapy
1.8Gy/d, d1-5/week, 34Fx
Drug: Paclitaxel and Carboplatin
patients get Paclitaxel and Carboplatin according to protocol
Other Names:
  • TC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 1year, 2 years, 3 years
1year, 2 years, 3 years
adverse event
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Shanxi Province Cancer Hospital
Jiangxi Provincial Cancer Hospital
Jiangsu Cancer Institute & Hospital
The First Affiliated Hospital of Xiamen University
Huadong Hospital
Gansu Cancer Hospital
Wuxi No. 4 People's Hospital

Investigators

  • Study Chair: Kuaile Zhao, MD, +86 18017312534

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

July 1, 2020

Study Completion (ACTUAL)

February 1, 2022

Study Registration Dates

First Submitted

May 23, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (ESTIMATE)

June 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO-Shanghai 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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