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

Henan Cancer Hospital

Status: Withdrawn

Conditions: Esophageal Cancer; Lung Cancer; Hyperthermic Perfusion

Treatments: Other: hyperthermic perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03110939

HenanCH2016ct082

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

hyperthermic perfusion group

Experimental group

Description:

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

Treatment:

Other: hyperthermic perfusion

control group

No Intervention group

Description:

standard surgery of advanced lung cancer/esophageal cancer