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

NCT03110939 | Withdrawn DMC

• 1 other identifier: HenanCH2016ct082
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Lung Cancer; Hyperthermic Perfusion

Outcome Measures

Primary Outcomes (1)

• local recurrent rate

  recurrent within thoracic cavity

  3 years after surgery

Secondary Outcomes (5)

• 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

• vital signs during treatment

  during operation/intrathoracic hyperthermic perfusion

• mortality rate after treatment

  2 months after surgery/intrathoracic hyperthermic perfusion

Study Arms (2)

hyperthermic perfusion group

EXPERIMENTAL

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

control group

NO INTERVENTION

standard surgery of advanced lung cancer/esophageal cancer

Interventions

hyperthermic perfusion OTHER

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

hyperthermic perfusion group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 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)
• Age ranges from 18 to 80 years.
• Without operative contraindication.
• Eastern Cooperative Oncology Group (ECOG) 0～2.
• Signed informed consent document on file.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of Henan Cancer Hospitan and director of thoracic surgery department

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 12, 2017
• Study Start: March 21, 2017
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2021
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CN (1)