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

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ClinicalTrials.gov Identifier: NCT03110939
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Yin Li, Henan Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Lung Cancer Hyperthermic Perfusion Other: hyperthermic perfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Single Center Randomized Controlled Trial of Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : April 5, 2019
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. local recurrent rate [ Time Frame: 3 years after surgery ]
    recurrent within thoracic cavity


Secondary Outcome Measures :
  1. Total complication rate [ Time Frame: 6 months after surgery ]
    The total complications mean anastomotic fistula, hydrothorax, pneumonia, pleural hemorrhage and cardiac together.

  2. The Clavien-Dindo classification [ Time Frame: 6 months after surgery ]
    the classification surgical complications after surgery/intrathoracic hyperthermic perfusion

  3. mortality rate during operation/intrathoracic hyperthermic perfusion [ Time Frame: during operation/intrathoracic hyperthermic perfusion ]
    mortality rate during operation/intrathoracic hyperthermic perfusion

  4. vital signs during treatment [ Time Frame: during operation/intrathoracic hyperthermic perfusion ]
    The heart rate, blood pressure and body temperature will be recorded every 10 mins during intrathoracic hyperthermic perfusion

  5. mortality rate after treatment [ Time Frame: 2 months after surgery/intrathoracic hyperthermic perfusion ]
    mortality rate after treatment



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110939


Locations
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China, Henan
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Recruiting
ZhengZhou, Henan, China, 450008
Contact: Yin Li, M.D.& Ph.D.    8613903838752    liyin825@aliyun.com   
Contact: Yan Zheng, M.D.& Ph.D.    8615713660065    sunnyzheng1@126.com   
Principal Investigator: Yin Li, M.D.& Ph.D         
Sponsors and Collaborators
Henan Cancer Hospital

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Responsible Party: Yin Li, vice president of Henan Cancer Hospitan and director of thoracic surgery department, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03110939     History of Changes
Other Study ID Numbers: HenanCH2016ct082
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Esophageal Neoplasms
Fever
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Body Temperature Changes
Signs and Symptoms