Regional Anesthesia and Endometrial Cancer Recurrence

NCT00531349 | Withdrawn Phase 3 DMC

• 1 other identifier: 07-532
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether recurrence of local and metastatic cancer after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane anesthesia and opioid analgesia.

Conditions

Cancer

Keywords

Endometrial Cancer; Anesthesia; regional; cancer recurrence; Analgesia; opioid

Outcome Measures

Primary Outcomes (1)

• Time to metastatic spread or local cancer recurrence

  every six months throughout the study, yearly thereafter

Secondary Outcomes (1)

• Any-cause mortality

  4.4 years, 6.0 years, 7.5 years and if needed 8.9 years

Study Arms (2)

A

ACTIVE COMPARATOR

General anesthesia and opioid analgesia for the treatment of pain after surgery.

Drug: Sevoflurane

B

ACTIVE COMPARATOR

Regional anesthesia and analgesia (epidural) combined with deep sedation or general anesthesia.

Procedure: propofol general anesthesia

Interventions

propofol general anesthesia PROCEDURE

Regional analgesia combined with sedation or a propofol general anesthesia

Also known as: propofol

B

Sevoflurane DRUG

General anesthesia

A

Eligibility Criteria

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

You may qualify if:

• Primary endometrial cancer without known extension beyond the uterus i.e., believed to be Stage 1 or 2
• Scheduled for open abdominal hysterectomy
• Written informed consent, including willingness to be randomized epidural anesthesia/analgesia with sedation or to sevoflurane general anesthesia and postoperative opioid analgesia

You may not qualify if:

• Previous surgery for endometrial cancer
• Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy)
• Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
• Age \< 18 or \> 85 years old
• ASA Physical Status ≥ 4
• Any contraindication to epidural anesthesia and analgesia (including coagulopathy, abnormal anatomy)
• Other cancer not believed by the attending surgeon to be in long-term remission
• Systemic disease believed by the attending surgeon or anesthesiologist to present ≥ 25% two-year mortality

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44129, United States

Location

MeSH Terms

Conditions

Neoplasms; Endometrial Neoplasms; Agnosia

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Daniel I. Sessler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I. Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)