A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587093
• Other study ID #: 01-048
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: February 20, 2018
• Start date: July 2001
• Est. completion date: February 16, 2018

Study information

• Verified date: February 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to determine if blood tests and a CT scan done before surgery can predict how successful the surgery will be. In patients who have cancer of the ovary that has spread, it is hoped that the CT scan will be able to identify the various places where the cancer has spread so that additional surgeons can be available to help with the surgical procedure.

If you have confirmed stage 3 or 4 ovarian, fallopian tube, or primary peritoneal cancer, you may undergo a CT scan of the abdomen and pelvis after the surgery to compare how much cancer the surgeon thought was left after surgery to what is seen on CT scan. A CT scan of the chest will be done if your physician thinks it is necessary.

Description:

This study is designed to assess the utility and impact of computed tomography (CT)scanning of the abdomen and pelvis and preoperative serum CA-125 levels in the management of patients undergoing surgery for presumed ovarian cancer.

Other known NCT identifiers

• NCT00502151

Recruitment information / eligibility

• Status: Completed
• Enrollment: 669
• Est. completion date: February 16, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients > 18 years of age undergoing surgery for presumed ovarian, fallopian tube, or primary peritoneal cancer.

• Patients must be medically and physically able to undergo general anesthesia and possible tumor debulking.

• Patients must read and sign informed consent form after the nature of the study has been fully explained.

Exclusion Criteria:

• Presence of clinically significant disease, allergy, or other disorder precluding the ability to safely perform CT scan of the abdomen and pelvis with oral and intravenous contrast.

• Vulnerable patients (minors, mentally retarded patients, prisoners, etc.)

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• CA 125 and CT scan
Within 14 days prior to surgery serum for CA125 will be obtained. The patient will also undergo a CT scan of the abdomen and pelvis with oral and intravenous contrast within 35 days prior to the procedure.

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Md Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Johns Hopkins University, M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of preoperative CT scan of the abdomen and pelvis in predicting optimal primary cytoreduction in advanced ovarian cancer.		7 - 35 days postop stage 3 or 4 disease CTscan have
Secondary	To evaluate the ability of preoperative serum CA-125 to predict optimal primary cytoreduction of advanced ovarian cancer.		Within 14 days prior to surgery
Secondary	To develop preoperative CT scan of the abdomen and pelvis and/or tumor marker criteria for ovarian cancer non-resectability (sub-optimal tumor cytoreduction).		3 years
Secondary	To determine the ability of preoperative CT scan of the abdomen and pelvis to provide useful information that will impact on surgical planning.		3 years
Secondary	To compare the intraoperative assessment of residual disease to that found on postoperative CT scan of the abdomen and pelvis, if scans are available for review.		3 years

External Links

•   Memorial Sloan Kettering Cancer Center