Overview

This trial is active, not recruiting.

Condition ovarian cancer
Treatment ca 125 and ct scan
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Johns Hopkins University
Start date July 2001
End date July 2016
Trial size 600 participants
Trial identifier NCT00587093, 01-048, NCT00502151

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
CT scan and CA-125
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.

Primary Outcomes

Measure
To assess the efficacy of preoperative CT scan of the abdomen and pelvis in predicting optimal primary cytoreduction in advanced ovarian cancer.
time frame: 7 - 35 days postop stage 3 or 4 disease CTscan have

Secondary Outcomes

Measure
To evaluate the ability of preoperative serum CA-125 to predict optimal primary cytoreduction of advanced ovarian cancer.
time frame: 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).
time frame: 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.
time frame: 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.
time frame: 3 years

Eligibility Criteria

Female participants at least 18 years old.

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.)

Additional Information

Official title Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer
Principal investigator Dennis Chi, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.