Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT01442051
Eligibility Criteria:
Inclusion Criteria:
* The study population will include women with a high preoperative suspicion of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Stage IIIC or IV) as determined by CT or MRI of abdomen and pelvis planning to undergo exploratory laparotomy and surgical cytoreduction with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
* Age ≥ 18 years and \< 70 years.
* Preoperative hemoglobin concentration ≥ 10 mg/dL within 30 days of registration.
* Based on surgeon's assessment, patient is recommended to undergo cytoreductive surgery via laparotomy with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
Exclusion Criteria:
* Hemoglobin \< 10 g/dL.
* Serum albumin \< 3g/dL.
* GOG performance status \> 2.
* Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
* Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within 30 days of enrollment.
* History of cerebrovascular disease.
* Renal insufficiency with serum creatinine \> 1.6.
* Uncontrolled hypertension.
* Restrictive or obstructive pulmonary disease.
* Congestive heart failure.
* Active infection.
* Pregnancy.
* Refusal to accept allogenic or autologous blood transfusion.
* Autologous blood transfusion within last 30 days or plan to donate autologous blood prior to surgery.
* Plan for exploratory laparoscopy prior to laparotomy for assessment of disease resectability.
* Surgeon has high suspicion (\>50% chance) that cytoreductive surgery will be aborted due to inability to achieve optimal cytoreduction to \< 1cm residual disease.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01442051
Study Brief:
Protocol Section:
NCT01442051