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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03110939

Enrollment

Registered

2017-04-12

Start date

2017-03-21

Completion date

2021-04-05

Last updated

2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Hyperthermic Perfusion, Lung Cancer

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.

Interventions

OTHERhyperthermic perfusion

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
local recurrent rate	3 years after surgery	recurrent within thoracic cavity

Secondary

Measure	Time frame	Description
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
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
mortality rate after treatment	2 months after surgery/intrathoracic hyperthermic perfusion	mortality rate after treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026