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Establishing Best Treatment Strategy for T4 Esophageal Cancer

ConditionEsophageal Cancer TNM Staging Primary Tumor (T) T4
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNational Cheng-Kung University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed esophageal squamous cell carcinoma

Tumor or lymph nodes invade adjacent organs (T4 stage)

Aged between 18-70 years old

Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) <2

Disqualifiers

Previous chemotherapy history

Myocardial infarction within the last three months

History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema

Has other malignancies currently

Trial design

Design model

Single group

Treatments tested in this trial

  • "Docetaxel", "Cisplatin", "fluorouracil", "Radiation"

    Combination product

    Induction chemotherapy with Docetaxel, Cisplatin, and fluorouracil for 4 to 8 cycles, followed by concurrent chemoradiotherapy with Cisplatin and Radiation 30.6-40 Gy.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Induction chemotherapy followed by chemoradiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate of the treatment

Overall response rate = complete response (CR) rate + partial response (PR) rate.

Time frame
At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
2

Duration of response (DOR)

Defined as the time from CR or PR to the time of disease progression or death.

Time frame
At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.

Secondary outcomes

1

Esophageal perforation rate

Detected by bronchoscopy or CT scan.

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.
2

Adverse events of treatment

Any adverse events of chemotherapy or CCRT.

Time frame
During treatment (up to 24 weeks)
3

Progression-free survival

Defined as the time from diagnosis to the time of disease progression or death.

Time frame
At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
4

Overall survival time

Defined as the time from diagnosis to the time of death.

Time frame
At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cheng-Kung University Hospital

Lead sponsor

Source ClinicalTrials.gov
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