Regional Anesthesia and Lung Cancer Recurrence

NCT01179308 | Terminated

• 1 other identifier: 10-610
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 2

Brief Summary

Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to general anesthesia alone.

Conditions

Lung Cancer

Keywords

regional analgesia; routine general anesthesia; immune system response; lung cancer (stage 1-3)

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  The effect of regional versus general anesthesia on the primary outcome of disease-free survival (time to the earlier or recurrence or death from any cause)

  up to 5 years after surgery

Secondary Outcomes (3)

• NK cell function

  up to three years post procedure

• Immune function markers

  for up to 3 years post procedure

• Pain

  up to 3 years post proceudure

Study Arms (2)

General-epidural anesthesia

ACTIVE COMPARATOR

Epidural and general anesthesia

Other: General-epidural anesthesia

General anesthesia

ACTIVE COMPARATOR

General anesthesia alone

Other: Balanced general anesthesia and postoperative opioids

Interventions

General-epidural anesthesia OTHER

General anesthesia combined with epidural anesthesia

General-epidural anesthesia

Balanced general anesthesia and postoperative opioids OTHER

General anesthesia alone

General anesthesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary non-small cell lung cancer (stage 1-3) as determined according to the IASLC Lung Cancer Staging Project;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrea Kurz, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); US (1)