Esophageal Cancer TNM Staging Primary Tumor (T) T4
Conditions
Keywords
T4 esophageal cancer, Induction chemotherapy
Brief summary
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
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.
Interventions
COMBINATION_PRODUCTDocetaxel, 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.
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will receive an induction chemotherapy regimen consisting of 4-8 cycles of docetaxel, cisplatin, and fluorouracil. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate of the treatment | 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. |
| Duration of response (DOR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal perforation rate | 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. |
| Adverse events of treatment | During treatment (up to 24 weeks) | Any adverse events of chemotherapy or CCRT. |
| Progression-free survival | 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. |
| Overall survival time | 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. |
Countries
Taiwan
Contacts
Primary ContactWei-Lun Chang, PhD
Backup ContactChing-Lin Wu, Master
Outcome results
None listed