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

Henan Cancer Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Esophageal Cancer Lung Cancer Hyperthermic Perfusion

Interventions

hyperthermic perfusionOTHER

hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after surgery of advanced lung cancer/esophageal cancer)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must not have received any prior anticancer therapy of cancer. 2. expected R0 resection. 3. 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) 4. Age ranges from 18 to 80 years. 5. Without operative contraindication. 6. Eastern Cooperative Oncology Group (ECOG) 0～2. 7. Signed informed consent document on file. Exclusion Criteria: 1. Multiple primary cancer. 2. The subject cannot understand and sign the informed consent form(ICF). 3. Patients with concomitant hemorrhagic disease. 4. Any un expected reason for patients can't get operation. 5. Pregnant or breast feeding.

Locations (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

local recurrent rate

recurrent within thoracic cavity

Time frame: 3 years after surgery

Secondary Outcomes

Total complication rate

The total complications mean anastomotic fistula, hydrothorax, pneumonia, pleural hemorrhage and cardiac together.

Time frame: 6 months after surgery

The Clavien-Dindo classification

the classification surgical complications after surgery/intrathoracic hyperthermic perfusion

Time frame: 6 months after surgery

mortality rate during operation/intrathoracic hyperthermic perfusion

Time frame: 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

Time frame: during operation/intrathoracic hyperthermic perfusion

mortality rate after treatment

Time frame: 2 months after surgery/intrathoracic hyperthermic perfusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.