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

Not Applicable

Completed

• Conditions: Ovarian Cancer
• Interventions: Other: CA 125 and CT scan

• Registration Number: NCT00587093
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Status Verified: 2018-02
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-16
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 669

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.

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CA 125 and CT scan	CT scan and CA-125

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To evaluate the ability of preoperative serum CA-125 to predict optimal primary cytoreduction of advanced ovarian cancer.	Within 14 days prior to surgery
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
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
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

Trial Locations

Locations (5)

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, United States

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Memoral Sloan Kettering Cancer Center; 🇺🇸 Basking Ridge, New Jersey, United States