Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins

Rectal Cancer Clinical Trial

Official title:

Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189877
• Other study ID #: 10-121
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: October 10, 2012
• Start date: August 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells that are oxygen-starved respond differently to treatment such as chemotherapy and radiation when compared to cells that are oxygen rich.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Biopsy proven adenocarcinoma of the rectum. If a biopsy was taken at an outside hospital, the slides and diagnosis will be reviewed and confirmed by a pathologist at MSKCC.

• Mid to distal rectal tumors not requiring pre-op radiation or chemotherapy

• Age = 18

• Age < 90

• Karnofsky performance status = 60

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Current pregnancy

• Uncontrolled intercurrent illness that would limit compliance with study requirements.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Eppendorf hypoximeter
Patients consented to the protocol will proceed to their surgery date without any change in the standard preoperative period. After arriving in the operating room, the patient will undergo intravenous general anesthesia (or spinal/epidural anesthesia) by the anesthesiologist and will receive 40% oxygen. At this time, the principal investigator (along with the assistance of the operating surgeon and a member of the Department of Medical Physics) will use the Eppendorf hypoximeter to gather pO2 measurements. We anticipate that this will add no more than fifteen minutes to the planned procedure. Once the measurements are collected, the anesthesia will be adjusted as appropriate for the surgery and the procedure will continue as usual.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure pO2 in rectal cancers	Measure pO2 in rectal cancers	2 years	No
Secondary	Correlate immunohistochemical analysis of endogenous markers of hypoxia	with direct tumor hypoximetry in tumor and normal tissue.	2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center