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

Not Applicable

Withdrawn

• Conditions: Hyperthermic Perfusion; Lung Cancer; Esophageal Cancer
• Interventions: Other: hyperthermic perfusion

• Registration Number: NCT03110939
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-21
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Primary Completion: 2019-04-05
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-22
• Study Completion: 2021-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
local recurrent rate	3 years after surgery	recurrent within thoracic cavity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university; 🇨🇳 ZhengZhou, Henan, China