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

Henan Cancer Hospital1 site in 1 countryMarch 21, 2017

ConditionsEsophageal Cancer Lung Cancer Hyperthermic Perfusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Esophageal Cancer
Sponsor: Henan Cancer Hospital
Locations: 1
Primary Endpoint: local recurrent rate
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 21, 2017

End Date

April 5, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Henan Cancer Hospital

Responsible Party

Principal Investigator

Yin Li

vice president of Henan Cancer Hospitan and director of thoracic surgery department

Henan Cancer Hospital

Eligibility Criteria

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, N
•(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～
•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.

Outcomes

Primary Outcomes

local recurrent rate

Time Frame: 3 years after surgery

recurrent within thoracic cavity

Secondary Outcomes

mortality rate after treatment(2 months after surgery/intrathoracic hyperthermic perfusion)
vital signs during treatment(during operation/intrathoracic hyperthermic perfusion)
Total complication rate(6 months after surgery)
The Clavien-Dindo classification(6 months after surgery)
mortality rate during operation/intrathoracic hyperthermic perfusion(during operation/intrathoracic hyperthermic perfusion)