Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

August 1, 2023 updated by: Kuai Le Zhao, MD, Fudan University
The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

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, China, 200032
        • Fudan University Shanghai Cancer Center

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

Description

Inclusion Criteria:

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75;
  • ECOG 0-2;
  • Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
  • The operative incision healed well;
  • T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
  • No radiotherapy, chemotherapy or other treatments pre (post) surgery;
  • PS ECOG 0-2;
  • Life expectancy of more than 3 months;
  • Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 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 after surgery, Esophageal perforation, Haematemesis;
  • 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;
  • Unsuitable to be enrolled in the trial in the opinion of the investigators.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concurrent chemoradiotherapy group

Interventions:

  • Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5
  • Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
Drug: Paclitaxel
paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
Drug: Carboplatin
carboplatin AUC=2, ivgtt, d1, qw*5
Radiation: Radiotherapy
1.8Gy/d, d1-5/week, 28Fx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local control rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Kuaile Zhao, Fudan University

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)

May 30, 2020

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO- Shanghai 17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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