search
Back to results

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

Primary Purpose

Esophageal Cancer, Lung Cancer, Hyperthermic Perfusion

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hyperthermic perfusion
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

hyperthermic perfusion group

control group

Arm Description

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

standard surgery of advanced lung cancer/esophageal cancer

Outcomes

Primary Outcome Measures

local recurrent rate
recurrent within thoracic cavity

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2017
Last Updated
January 20, 2020
Sponsor
Henan Cancer Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03110939
Brief Title
Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
Official Title
A Phase III, Single Center Randomized Controlled Trial of Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The principal investigator Dr.YinLi is working in other Hospital
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
April 5, 2019 (Anticipated)
Study Completion Date
April 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Lung Cancer, Hyperthermic Perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyperthermic perfusion group
Arm Type
Experimental
Arm Description
hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after standard surgery of advanced lung cancer/esophageal cancer)
Arm Title
control group
Arm Type
No Intervention
Arm Description
standard surgery of advanced lung cancer/esophageal cancer
Intervention Type
Other
Intervention Name(s)
hyperthermic perfusion
Intervention Description
hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after surgery of advanced lung cancer/esophageal cancer)
Primary Outcome Measure Information:
Title
local recurrent rate
Description
recurrent within thoracic cavity
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
Total complication rate
Description
The total complications mean anastomotic fistula, hydrothorax, pneumonia, pleural hemorrhage and cardiac together.
Time Frame
6 months after surgery
Title
The Clavien-Dindo classification
Description
the classification surgical complications after surgery/intrathoracic hyperthermic perfusion
Time Frame
6 months after surgery
Title
mortality rate during operation/intrathoracic hyperthermic perfusion
Description
mortality rate during operation/intrathoracic hyperthermic perfusion
Time Frame
during operation/intrathoracic hyperthermic perfusion
Title
vital signs during treatment
Description
The heart rate, blood pressure and body temperature will be recorded every 10 mins during intrathoracic hyperthermic perfusion
Time Frame
during operation/intrathoracic hyperthermic perfusion
Title
mortality rate after treatment
Description
mortality rate after treatment
Time Frame
2 months after surgery/intrathoracic hyperthermic perfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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, 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. 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.
Facility Information:
Facility Name
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
City
ZhengZhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs