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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00634894
Eligibility Criteria:
Inclusion Criteria:
1. Patients with optimally debulked (\< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer that have achieved a complete clinical response (CR) to first-line surgery and chemotherapy.
2. All patients must have had appropriate surgery with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.
3. Patients must have completed primary treatment within the past 8 weeks and received at least 5 cycles and not more than 8 cycles of a platinum (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy. Patients must have no symptoms suggestive of persistent cancer.
4. Patient must have a CT or MRI scan of the abdomen/pelvis with no evidence of metastatic disease and a normal CA-125 (\< 35 Units/mL) following primary therapy.
5. Patients willing to sign informed consent to participate in study for 5 years or until first recurrence.
Exclusion Criteria:
1. Patients with any evidence of metastatic disease after completion of surgery and first line chemotherapy
2. Patients with low grade ovarian cancer histology.
3. If chemotherapy initiated greater than 8 weeks after primary surgery or completed more than 8 weeks prior to treatment start.
4. Patients that received neoadjuvant chemotherapy.
5. Patients taking any form of HRT and/or CAM products (i.e. phytoestrogens, etc.)
6. Patients with history of prothrombic clotting disorders (i.e PE or DVT).
7. Patients with history of malignant disease within past 10 years except for squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
8. Patients with severe concomitant disease which would place patient at unusual risk or confound the results of the trial.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00634894
Study Brief:
Protocol Section:
NCT00634894