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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03110939
• Other study ID #: HenanCH2016ct082
• Status: Withdrawn
• Phase: N/A
• Start date: March 21, 2017
• Est. completion date: April 5, 2021

Study information

• Verified date: January 2020
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Fever
• Hyperthermic Perfusion
• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	ZhengZhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local recurrent rate	recurrent within thoracic cavity	3 years after surgery
Secondary	Total complication rate	The total complications mean anastomotic fistula, hydrothorax, pneumonia, pleural hemorrhage and cardiac together.	6 months after surgery
Secondary	The Clavien-Dindo classification	the classification surgical complications after surgery/intrathoracic hyperthermic perfusion	6 months after surgery
Secondary	mortality rate during operation/intrathoracic hyperthermic perfusion	mortality rate during operation/intrathoracic hyperthermic perfusion	during operation/intrathoracic hyperthermic perfusion
Secondary	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
Secondary	mortality rate after treatment	mortality rate after treatment	2 months after surgery/intrathoracic hyperthermic perfusion