Establishing Best Treatment Strategy for T4 Esophageal Cancer

September 16, 2025 updated by: National Cheng-Kung University Hospital

A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer

The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are:

  • Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate?
  • Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer.

Participants will:

  • Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3
  • Visit the clinic once every week for checkups and tests
  • Keep a diary of their symptoms

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer. The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy. The study will be conducted in two phases, starting with a phase I study to determine safety, followed by a phase II study to evaluate overall efficacy. Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer, offering a better treatment option for these patients.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Phase 2
  • Phase 1

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

Study Contact Backup

Study Locations

  • Taiwan
    • Taiwan
      • Tainan City, Taiwan, Taiwan, 704302

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed esophageal squamous cell carcinoma
  2. Tumor or lymph nodes invade adjacent organs (T4 stage)
  3. Aged between 18-70 years old
  4. Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) <2
  5. Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10^3/L, platelet count ≥ 100×10^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min.

Exclusion Criteria:

  1. Previous chemotherapy history
  2. Myocardial infarction within the last three months
  3. History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema
  4. Has other malignancies currently
  5. Uncontrolled infection
  6. Pregnancy or lactation
  7. Perforated esophagus at the time of diagnosis

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: Induction chemotherapy followed by chemoradiotherapy
This is a single-arm study. All patients will be assigned to receive Induction chemotherapy followed by concurrent chemoradiotherapy.
Combination product: "Docetaxel", "Cisplatin", "fluorouracil", "Radiation"
Induction chemotherapy with Docetaxel, Cisplatin, and fluorouracil for 4 to 8 cycles, followed by concurrent chemoradiotherapy with Cisplatin and Radiation 30.6-40 Gy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate of the treatment
Time Frame: At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
Overall response rate = complete response (CR) rate + partial response (PR) rate.
At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
Duration of response (DOR)
Time Frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Defined as the time from CR or PR to the time of disease progression or death.
At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal perforation rate
Time Frame: At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.
Detected by bronchoscopy or CT scan.
At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.
Adverse events of treatment
Time Frame: During treatment (up to 24 weeks)
Any adverse events of chemotherapy or CCRT.
During treatment (up to 24 weeks)
Progression-free survival
Time Frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Defined as the time from diagnosis to the time of disease progression or death.
At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Overall survival time
Time Frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Defined as the time from diagnosis to the time of death.
At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.

Collaborators and Investigators

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

Sponsor

National Cheng-Kung University Hospital

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)

August 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-BR-113-045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared. Results will be published by the investigators in academic journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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