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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT00500435
Eligibility Criteria:
Inclusion Criteria:
* Patients with stage IB2-IVA cervical cancer who are candidates for treatment with radiotherapy and concurrent chemotherapy.
* Patients with biopsy-proven cervical carcinoma, any histology.
* Patients must have no evidence of para aortic lymphadenopathy (\< 2cm in diameter) on the preoperative computed tomography (CT) or magnetic resonance imaging (MRI) scan of the abdomen and pelvis.
* Patients must sign an IRB approved informed consent.
* Patients with adequate bone marrow, renal and hepatic function: White Blood Count (WBC) \>/= 3,000 cells/mcl, Platelets \>/= 100,000/mcl, Creatinine \</= 2.0 mg%, Bilirubin \</= 1.5 x the upper limit of normal and Serum glutamic pyruvic transaminase (SGPT) \</= 3 x the upper limit of normal.
* Zubrod Performance Status of 0, 1, or 2.
* Patients must be suitable candidates for surgery.
* Patients who had a PET/CT scan prior to study entry are eligible if a) the study was done within 4 weeks of surgery, and b) they have no evidence of para aortic lymphadenopathy (\< 2cm in diameter) on either a preoperative CT or MRI scan of the abdomen and pelvis.
Exclusion Criteria:
* Patients who have had prior retroperitoneal surgery.
* Patients who have received prior pelvic or abdominal radiotherapy.
* Patients known to have upper abdominal intraperitoneal disease or evidence of ovarian metastases.
* Patients who are pregnant.
* Patients with evidence of distant metastases on chest x-ray, CT or MRI scan or by physical examination.
* Patients with contraindications to laparoscopy.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00500435
Study Brief:
Protocol Section:
NCT00500435