Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma

August 29, 2015 updated by: Jie He, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

  • Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
  • No standard postoperative adjuvant chemotherapy has ever been established.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

386

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 Contact

  • Name: Jing Huang
  • Phone Number: 8610-87788102

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Jie He, M.D.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ability to give informed consent
  • histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
  • node-positive and pathologic stage M0
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients were enrolled 4 to 10 weeks after surgery
  • Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits

Exclusion Criteria:

  • prior chemotherapy or concurrent radiation therapy before esophagectomy
  • R1 or R2 resection
  • clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
chemotherapy and radiotherapy
Radiation: radiation
radiation
Drug: paclitaxel; cisplatin
The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.
Active Comparator: Arm B
radiotherapy
Radiation: radiation
radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 year relapse free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
3 year overall survival
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Time Frame
5 year overall survival
Time Frame: 8 years
8 years

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

April 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 30, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 29, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-GI-046

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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