Active clinical trials for "Endometrial Neoplasms"

The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients. The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account. The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer. Secondary endpoints include: bleeding complications conversions number of pelvic lymph nodes

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.

Recent findings have suggested that laparoscopic surgery is safe and effective, as well as laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover, our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or lymphovascular space invasion. Based on these considerations, the aim of the current protocol-study will be to compare two different strategies for vaginal cuff recurrences prevention in patients affected by ESEC treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation will be compared to post-operative brachytherapy.

Endometrial (uterine) cancer affects over 40,000 women each year in the United States. At this time there are no medications to prevent endometrial cancer. Women who are heavy are at increased risk of this cancer. Progestins have been used to treat endometrial hyperplasia and cancer in women who wanted to retain their fertility or who were not surgical candidates. Oral progestins are associated with side effects such as weight gain, mood changes, headaches, and acne. A device called Mirena has a type of progesterone in it. Because it is placed directly in the uterus it can give a powerful amount of progestin with less side effects. In this project, we will enroll 44 women who are aged 40-50 and who have a body mass index (BMI) greater than 40. (BMI is a measure of obesity. Normal is less than 25.) They will be randomized to either observation or treatment. The women in the treatment group will have a levonorgestrel intrauterine system (Mirena, LNG-IUS) placed for one year. All of the women will have endometrial biopsies and blood work at the beginning and end of the study. All of the women will have an ultrasound at the beginning of the study. The information will then be used to assess whether or not the LNG-IUS will be an effective prevention agent. The women will be contacted once a year for 5 years to see if they have had endometrial hyperplasia or cancer. A special lab study called microarray will be used to see what genes are turned on or off in the uterine lining.

The aim of this randomized controlled trial is to demonstrate that a nurse-led sexual rehabilitation intervention significantly improves sexual recovery and functioning among gynaecological cancer (GC) patients treated with radiotherapy (RT), compared with usual care (i.e., oral information by a nurse or doctor and written information). Women with GC (n=220) who receive RT in one of the participating Dutch GC centres (n=9) will be randomized to either the sexual rehabilitation intervention (n= 110) or usual care (n= 110), stratified for combined RTBT vs. RT alone, and for having a partner (yes/no). Women are eligible for participation if they: have been diagnosed with either cervical, endometrial, or vaginal cancer; are treated with radiotherapy; are 18 years or older; and wish to retain their sexual activity on the short or long term. The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT. Women who received RTBT will receive an additional appointment with the nurse (2 months after RTBT) to promote regular use of vaginal dilators in order to prevent stenosis. Participants are requested to complete questionnaires at baseline and at 1, 3, 6, and 12 months post-RT. The primary endpoint is sexual functioning at 12 months. Secondary endpoints include vaginal symptoms and body concerns, fear of coital and non-coital sexual activity, sexual distress, treatment-related distress, generic health-related quality of life, psychological distress, and relationship dissatisfaction. Hypothesis: The investigators expect women who receive the nurse-led sexual rehabilitation programme to report a greater improvement in sexual functioning from immediate post-radiotherapy to 1 year post-radiotherapy than women in the control group.

The purpose of this trial is to evaluate the safety of sequential and concurrent carboplatin and paclitaxel with adjuvant external beam radiotherapy for locally advanced endometrial cancer. The primary objective is to assess the acute toxicities namely grade 3-4 non hematologic and grade 4 hematologic toxicities associated with the above regimen. The null hypothesis is that the unacceptable toxic response rate is ≥40%. This will be tested against a one-sided alternative that the toxicity rate is 20% or less. Simon's two-stage design was used to power this aim. In the first stage, 11 patients will be accrued. If there are 5 or more toxic responses in these 11 patients, the study will be stopped for safety reasons. Otherwise, 13 additional patients will be accrued for a total of 24 patients. Under these conditions, the probability of stopping early is 47% if the toxic response rate is truly higher than 20.0%. If this regimen is safe then its efficacy can be studied in a Phase III study.

This study aims to test the hypothesis that combining serabelisib, a PI3K alpha isoform inhibitor, with an SGLT2 inhibitor, canagliflozin will improve efficacy in the treatment of patients with advanced solid tumors.

This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with advanced and recurrent endometrial carcinoma.The primary hypothesis of this study are that patients with advanced and recurrent endometrial carcinoma could benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; 2) Objective Response Rate (ORR); and Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.

Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with olaparib in patients with advanced solid tumors.

To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.