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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Johns Hopkins University
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00587093
First received: December 21, 2007
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Ovarian Cancer
Other: CA 125 and CT scan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2001
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
CT scan and CA-125
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587093

Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
Md Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Johns Hopkins University
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Dennis Chi, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00587093     History of Changes
Obsolete Identifiers: NCT00502151
Other Study ID Numbers: 01-048
Study First Received: December 21, 2007
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Newly diagnosed
CA 125
CT scan
01-048

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 22, 2014