Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer

Study Overview
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Brief Summary
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The goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after surgery.

Official Title
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A Phase III, Single Center Randomized Controlled Trial of Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer

Conditions
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Esophageal Cancer, Lung Cancer, Hyperthermic Perfusion

Intervention / Treatment
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* Other: hyperthermic perfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must not have received any prior anticancer therapy of cancer. expected R0 resection. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of T3-4, any N and any T, N1. (8th Union for International Cancer Control, Union for International Cancer Control(UICC)-TNM). Histologic diagnosis of non small cell lung cancer, T2-T3, any N. (8th Union for International Cancer Control, UICC-TNM) Age ranges from 18 to 80 years. Without operative contraindication. Eastern Cooperative Oncology Group (ECOG) 0～2. Signed informed consent document on file. Exclusion Criteria: Multiple primary cancer. The subject cannot understand and sign the informed consent form(ICF). Patients with concomitant hemorrhagic disease. Any un expected reason for patients can't get operation. Pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyperthermic perfusion group<br>hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after standard surgery of advanced lung cancer/esophageal cancer) | Other: hyperthermic perfusion<br>* hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after surgery of advanced lung cancer/esophageal cancer)<br>|
| No Intervention: control group<br>standard surgery of advanced lung cancer/esophageal cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrent rate | recurrent within thoracic cavity | 3 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total complication rate | The total complications mean anastomotic fistula, hydrothorax, pneumonia, pleural hemorrhage and cardiac together. | 6 months after surgery | 
| The Clavien-Dindo classification | the classification surgical complications after surgery/intrathoracic hyperthermic perfusion | 6 months after surgery | 
| mortality rate during operation/intrathoracic hyperthermic perfusion | mortality rate during operation/intrathoracic hyperthermic perfusion | during operation/intrathoracic hyperthermic perfusion | 
| vital signs during treatment | The heart rate, blood pressure and body temperature will be recorded every 10 mins during intrathoracic hyperthermic perfusion | during operation/intrathoracic hyperthermic perfusion | 
| mortality rate after treatment | mortality rate after treatment | 2 months after surgery/intrathoracic hyperthermic perfusion |