BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
Endometrial CancerThis is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.
Tachosil for the Prevention of Symptomatic Lymph Cysts
Endometrial CancerCervical CancerThis is a randomized trial of 140 women with endometrial or cervical cancer undergoing removal of lymph tissue (lymphadenectomy). The application of 4 tachosil fibrin patches to the pelvic side wall after tissue removal is tested against no such intervention after tissue removal. The primary endpoint is to evaluate the incidence of symptomatic pelvic lymphoceles defined by CTCAE 4.03 grade >2 within 4 weeks after surgery in women undergoing open or laparoscopic pelvic lymphadenectomy for cervical and endometrial cancer with and without the application of Tachosil® during surgery. The study's hypothesis is that the application of tachosil fibrin patches will significantly reduce the rate of symptomatic lymph cysts.
LUDEC Study - Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Endometrial Carcinoma...
Cancer of EndometriumCarcinoma of Endometrium1 moreThe current pilot study aims at answering the scientific question, whether exfoliated cells from Endometrium Carcinoma (EC) can be detected in the lavage fluid from the uterine cavity and proximal fallopian tubes with the same sensitivity as in specimen from liquid-based cervical cytology. If this turns out to be the case, earlier detection, particularly of type II EC should be possible.
Sentinel Lymph Node Detection in Endometrial Cancer
Endometrial NeoplasmsIn endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative risk group allocation is known to be erroneous in up to 15% of patients. A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential to spare extensive surgery in 80% of high risk patients, identify low risk patients with nodal metastases, diminish side effects caused by full lymphadenectomy and render some expensive preoperative risk group allocation measures unnecessary. A clinically useful SLN technique requires a high technical success rate, a clear definition of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of colored/ signaling nodes. Therefore, a definition of a SLN requires identification of efferent/afferent lymph vessels. Several publications describe sentinel node techniques in EC with a variety of tracers (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described as "radioactive nodes" or "colored nodes" only with no further discrimination. No study relate to an anatomical description of lymphatic pathways. The aims of this study is to systematically display the major anatomical pathways with the use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on lymphatic anatomy and identification of efferent lymph vessels.
Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers
Ovarian CancerEndometrial Cancer1 moreRationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly paclitaxel/carboplatin regimen in gynaecological cancers. Purpose: This multicenter phase II trial is studying the side effects of weekly paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or cervical carcinoma. Data obtained in this trial will be compared with historical data as published earlier. The trial will include 3 cohorts of 36 patients: Subjects with ovarian, fallopian tube or peritoneal carcinoma Subjects with endometrial cancer Subjects with cervical carcinoma Treatment: Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles of chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next 2 years and then if clinically indicated. Subjects who develop disease progression will discontinue therapy. Subjects who have no evidence of disease progression after completion of study therapy will be followed until disease progression, withdrawal of informed consent, or death.
S9630, Medroxyprogesterone in Treating Women With Breast Cancer
Breast CancerEndometrial CancerRATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen. PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ, lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II breast cancer and who are taking tamoxifen.
Predictors of Node Positivity in Endometrial Cancer
Endometrial CancerTo investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endoemtrila cancer patients.
PET/CT in the Management of Patients With Early Stage Endometrial Cancer
Endometrium CancerEndometrial cancer (EC) is the most common gynecologic malignancy in the developed countries and is the fifth most common cancer among women worldwide. Typically present well or moderately differentiated, early stage endometrioid histotype with a prognosis usually favorable. Pelvic lymph nodes (LNs) represent the most common site of extra-uterine disease in patients with clinical early stage disease and the role of lymphadenectomy in early stage EC has been one of the major controversies in gynecology oncology. Lymphadenectomy doesn't improve survival or reduce disease recurrence although supported to provide prognostic information and allowing tailoring of adjuvant therapy. Nevertheless, lymphadenectomy is not performed without serious short-term and long-term morbidity. Although surgical staging is the most accurate and standard method to determine LNs involvement, the introduction in clinical practice of a non-invasive modality that allows an accurate staging of EC would be essential. Available evidence report the accuracy of Positron Emission Tomography and Computed Tomography (PET/CT) for the detection of LN metastasis in EC with a sensitivity of 63% and specificity of 94.7%. This prospective comparative analysis between PET/CT, histological findings, and follow up data will be performed to investigate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of integrated PET/CT for nodal staging of EC per patient and per LN chain analyses, in women affected by intermediate (grade 1 and 2 endometrioid lesions with deep myometrial invasion > 50% or grade 3 endometrioid lesion with < 50% myometrial invasion) or high risk (grade 3 endometrioid lesion with deep myometrial invasion > 50% or non-endometrioid histotype) early-stage EC. Furthermore, the preoperative classification of EC in intermediate and high-risk class will allow to investigate its prognostic value.
Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery
Stage I Endometrial CarcinomaStage II Endometrial Carcinoma2 moreThis clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.
the Value of Immunohistochemical Expression of Moesin in Endometrial Hyperplasia and Endometrial...
Endometrial Cancer and Endometrial HyperplasiaEndometrial carcinoma (EC) is the most prevalent invasive carcinoma of the female genital tract in developed countries, while it ranks as the second most frequently occurring neoplasm of women in developing countries, after carcinoma of the cervix uteri. The vast majority of ECs occur in perimenopausal and postmenopausal women . ECs are classified into two distinct phenotypes; type I which represents more than 80% of all cases of ECs, it has a favorable prognosis. This type is linked to excess, unopposed hyper-estrogenic condition and it is almost always preceded by endometrial hyperplasia. On the contrary, type II endometrial carcinoma is less common than type I, representing less than 10% of all cases of ECs. Type II endometrial carcinomas are high grade, poorly differentiated and estrogen-independent tumors .