A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Kα Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer
The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.
NCT02725268 — Endometrial Neoplasms
Status: Completed
http://inclinicaltrials.com/endometrial-neoplasms/NCT02725268/
Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer
80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data have shown that caloric restriction (CR) protects against organ injury and decreases perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed endometrial cancer patients. The intervention will provide individualized CR program, meal replacement products and nutritional counselling sessions.
NCT02665962 — Endometrial Cancer
Status: Terminated
http://inclinicaltrials.com/endometrial-cancer/NCT02665962/
Lifestyle Interventions to Improve Physical Function and Quality of Life in Endometrial Cancer Survivors: The Role of a Gentle Yoga Based Exercise Program
This randomized clinical trial studies how well gentle yoga and dietary counseling lifestyle change effects physical function and quality of life of endometrial cancer survivors. Gentle yoga and dietary counseling may help improve physical function and quality of life for stage I-II endometrial cancer survivors.
NCT02465541 — Obesity
Status: Completed
http://inclinicaltrials.com/obesity/NCT02465541/
Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point. This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.
NCT02433080 — Endometrial Neoplasms
Status: Completed
http://inclinicaltrials.com/endometrial-neoplasms/NCT02433080/
Phase II Study of the Levonorgestrel Intrauterine Device Alone or in Combination With the mTORC1 Inhibitor, Everolimus, for the Treatment of Complex Atypical Hyperplasia and Stage Ia Grade 1 Endometrial Cancer
This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releasing intrauterine system is designed to prevent pregnancy by releasing a hormone called levonorgestrel, which is a type of progesterone. Progesterone is a common type of hormone that is used to prevent pregnancy and may prevent or slow tumor cell growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether the levonorgestrel-releasing intrauterine system works better with or without everolimus in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer.
NCT02397083 — Atypical Endometrial Hyperplasia
Status: Active, not recruiting
http://inclinicaltrials.com/atypical-endometrial-hyperplasia/NCT02397083/
Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study
This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or obesity is one of the most common contributors to (causes of) endometrial cancer. Over two-thirds of women who have survived endometrial cancer are obese. Complications of obesity, such as heart disease are often more dangerous than the cancer itself. A weight loss of even 5-10% of excess body weight is associated with improved health. Often, meeting with a doctor or person who is an expert in weight loss (bariatric specialist) is the best way to lose weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia who go see a weight loss specialist recommended by their doctor may be able to achieve a healthier body weight.
NCT02342730 — Stage II Uterine Corpus Cancer
Status: Completed
http://inclinicaltrials.com/stage-ii-uterine-corpus-cancer/NCT02342730/
A Phase 1 Open-label Study of the Selective Inhibitor of Nuclear Export, Selinexor (KPT-330) in Combination With Paclitaxel and Carboplatin in Patients With Advanced Ovarian or Endometrial Cancers
The purpose of this study is to test the safety of the investigational drug, selinexor (KPT-330), in combination with carboplatin and paclitaxel chemotherapy, where paclitaxel will be given at two different dosing schedules and selinexor will be given at two different dosing schedules. Carboplatin and paclitaxel chemotherapy is a commonly used therapy for the treatment of advanced or recurrent ovarian, fallopian tube, primary peritoneal, or endometrial cancer. The investigators want to find out what effects, good and/or bad, selinexor has on the patient and the cancer.
NCT02269293 — Ovarian Cancer
Status: Completed
http://inclinicaltrials.com/ovarian-cancer/NCT02269293/
The Feasibility and Benefits of Using Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer
Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG, sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will be identified. SLNs will be surgically removed and provided to Pathology for evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to Pathology for evaluation. A positive SLN may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.
NCT02131558 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT02131558/
Use of Fluorescence Imaging and High-Resolution Microendoscopy to Guide Hysteroscopic Tumor Resection in Patients With Endometrial Cancer
The goal of this clinical research study is to learn if imaging (called a hysteroscopy) can be used to help guide tumor removal during a hysterectomy.
NCT02095847 — Uterine Cancer
Status: Withdrawn
http://inclinicaltrials.com/uterine-cancer/NCT02095847/
A Translational Companion Protocol to GOG229O: A Randomized Phase II Study With a Safety Lead-In to Assess the Antitumor Efficacy of the MEK Inhibitor Trametinib Alone or in Combination With GSK2141795, an AKT Inhibitor, in Patients With Recurrent or Persistent Endometrial Cancer
This trial assesses blood and tumor samples for the effect of trametinib with or without uprosertib on biomarkers in patients enrolled on trial GOG02290 with endometrial cancer that is persistent or has come back. Biomarkers found in the blood and tissue may be related to the reaction or response to the study drugs.
NCT02093546 — Recurrent Endometrial Carcinoma
Status: Completed
http://inclinicaltrials.com/recurrent-endometrial-carcinoma/NCT02093546/