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

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.

Study Overview

• Status: Withdrawn
• Conditions: Esophageal Cancer; Lung Cancer; Hyperthermic Perfusion
• Intervention / Treatment: Other: hyperthermic perfusion

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • ZhengZhou, Henan, China, 450008
      • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hyperthermic perfusion group; hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after standard surgery of advanced lung cancer/esophageal cancer)	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)
No Intervention: control group; standard surgery of advanced lung cancer/esophageal cancer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total complication rate	The total complications mean anastomotic fistula, hydrothorax, pneumonia, pleural hemorrhage and cardiac together.	6 months after surgery
The Clavien-Dindo classification	the classification surgical complications after surgery/intrathoracic hyperthermic perfusion	6 months after surgery
mortality rate during operation/intrathoracic hyperthermic perfusion	mortality rate during operation/intrathoracic hyperthermic perfusion	during operation/intrathoracic hyperthermic perfusion
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
mortality rate after treatment	mortality rate after treatment	2 months after surgery/intrathoracic hyperthermic perfusion

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Anticipated): April 5, 2019
• Study Completion (Anticipated): April 5, 2021

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Wounds and Injuries; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Body Temperature Changes; Heat Stress Disorders; Lung Neoplasms; Hyperthermia; Fever; Esophageal Neoplasms
• Other Study ID Numbers: HenanCH2016ct082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No