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 @ 1:27 PM
Ignite Modification Date:
2025-12-24 @ 1:27 PM
NCT ID:
NCT00612495
Eligibility Criteria:
Inclusion Criteria:
* Patients aged at least 18 years, with locally advanced, recurrent or metastatic endometrial adenocarcinoma, histologically diagnosed; at least 1 bidimensionally measurable lesion (\> or =to 2 cm on computed tomography \[CT\]/magnetic resonance imaging \[MRI\] or \> or =to 1 cm clinical lymph node confirmed by ultrasound or \> or =to 1 cm skin lesion confirmed by photograph with ruler) located in a non-irradiated area measured less than 2 weeks before inclusion, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
* Patients previously treated for locally advanced/metastatic disease with chemo-radiotherapy (total CDDP dose \> or =to 100 mg/m2) or chemotherapy containing CDDP or carboplatin with at least 4 weeks' washout period from discontinuation of prior chemotherapy and fully recovered from toxic effects of prior chemotherapy (except for symptomatic peripheral neuropathy \< or =to NCI-CTC grade 1 or alopecia).
* Patients with clinically or radiologically documented PD or recurrence during or after last chemotherapy and hormone therapy (hormone therapy stopped before study entry), Eastern Cooperative Oncology Group performance status (ECOG PS) \< or =to 2, life expectancy \> or =to 3 months, adequate bone marrow reserve, normal renal and liver function (neutrophil count \> or =to 2000/mm³; platelet count \> or =to 100 000/mm³; creatinine levels \< or =to 1.5 x the upper limit of normal \[ULN\] of institutional values or creatinine clearance \> 60 mL/min; total bilirubin level \< 1.5 x ULN; \[alanine amino transferase/aspartate amino-transferase \< 2.5 x ULN without liver metastases, \< 5 x ULN with liver metastases\]).
* Laboratory values obtained in the week preceding study entry.
* Signed informed consent (prior to all study procedures)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00612495
Study Brief:
Protocol Section:
NCT00612495