The Effect of Combined General/Regional Anesthesia on Cancer Recurrence in Patients Having Lung Cancer Resections
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Surgery is the primary treatment of lung cancer, but surgery releases tumor cells into the systemic circulation. Whether this minimal residual disease results in clinical metastases is a function of host defense. At least three perioperative factors shift the balance toward initiation and progression of minimal residual disease.
- Surgery per se depresses cell-mediated immunity, reduces concentrations of tumor-related anti-angiogenic factors (e.g., angiostatin and endostatin), and increases concentrations of pro-angiogenic factors such as VEGF.
- Anesthesia impairs numerous immune functions, including neutrophil, macrophages, dendritic cells, T-cell, and NK-cell functions.
- Opioid analgesics inhibit both cellular and humoral immune function in humans, and promote tumor growth in rodents.
The primary hypothesis is that disease-free survival is improved in patients undergoing resection for tumor thought to be stage I-III primary non-small cell lung cancer in patients with combined general-epidural anesthesia & analgesia as compared to patients receiving general anesthesia and postoperative patient-controlled opioid analgesia. Patients having surgery for resection of potentially curable lung cancer will be randomized to combined general and epidural anesthesia or general anesthesia with opioid analgesia. The primary outcome will be disease-free survival.
The effect of combined epidural/general anesthesia versus general anesthesia with opioid analgesia on the primary outcome of disease-free survival (time to the earlier or recurrence or death from any cause) will be assessed uni-variably with Kaplan-Meier analyses and multivariably (primary analysis) with a Cox proportional hazards regression model adjusting for known risk factors for recurrence, including tumor stage, size of tumor, age, sex, receipt of chemotherapy before or after surgery, and clinical site. As usual for this type of analysis, stopping criteria will be based on number of outcome events rather than enrollment.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai, China
- Shanghai Chest Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Tumor thought to be primary non-small cell lung cancer (stage 1-3) as determined according to the IASLC Lung Cancer Staging Project[ref];
- Scheduled for potentially curative tumor resection;
- Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia plus general anesthesia or to general anesthesia and postoperative opioid analgesia;
- ASA physical status 1-3.
Exclusion Criteria:
- Any contraindication to epidural anesthesia, (including coagulopathy, abnormal anatomy).
- Any contraindication to midazolam, propofol, sevoflurane, fentanyl, morphine, or hydromorphone.
- Age <18 or >85 years old.
- Other cancer not believed by the attending surgeon to be in long-term remission.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Combined general/epidural anesthesia
Combined general/epidural anesthesia and analgesia.
General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs.
Epidural anesthesia will include bupivacaine and other local anesthetics.
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Combined general/epidural anesthesia and analgesia.
General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs.
Epidural anesthesia will include bupivacaine and other local anesthetics.
|
|
Experimental: General anesthesia with opioid analgesia
General anesthesia with routine drugs and intravenous PCA opioid analgesia.
General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs.
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General anesthesia with routine drugs and intravenous patient controlled opioid analgesia.
General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cancer-free survival
Time Frame: 3 years or as available
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Patients who remain alive without known lung cancer recurrence
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3 years or as available
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity
Time Frame: 2 days
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Time-weighted average pain scores over initial two days of hospitalization.
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2 days
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SF-12 Health Survey
Time Frame: 6, 12, 24, and 36 months
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6, 12, 24, and 36 months
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McGill Pain Questionnaire
Time Frame: 6, 12, 24, and 36 months
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6, 12, 24, and 36 months
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Neuropathic Pain Questionnaire
Time Frame: 6, 12, 24, and 36 months
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6, 12, 24, and 36 months
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Opioid use
Time Frame: 2 days
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Total opioid use
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2 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Daniel I Sessler, MD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 091051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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