A 3-Arm Randomised Phase II Evaluation of Cediranib in Combination With Weekly Paclitaxel or Olaparib Versus Weekly Paclitaxel Chemotherapy for Advanced Endometrial Carcinoma or for Disease Relapse Within 18 Months of Adjuvant Carboplatin-paclitaxel Chemotherapy.
The COPELIA trial is evaluating two new tablet medications in endometrial cancer for the first time. It will include 129 women aged 16 years or older with advanced endometrial cancer whose cancer has worsened after their initial chemotherapy treatment. Participants will be allocated at random to one of three groups: 1. The first group (Arm 1) will receive a standard (routine) treatment for patients with endometrial cancer known as paclitaxel. This is a chemotherapy drug that is routinely used to treat patients with different cancers including ovarian, breast, lung and endometrial cancer. Paclitaxel works by stopping the growth of cancer cells. 2. The second group (Arm 2) will receive the standard paclitaxel treatment once a week in addition to a new drug called cediranib. Cediranib is a tablet medication and works by blocking new blood vessel formation. Cediranib has been tested in women with endometrial cancer before but not alongside chemotherapy treatment. 3. The third group (Arm 3) will receive two new tablet medications, cediranib and olaparib. Olaparib works by preventing cancer cells repairing DNA effectively. The use of olaparib and cediranib together has been shown to be effective in a common type of ovarian cancer but has not been evaluated as a treatment for endometrial cancer before. The main objectives of the COPELIA trial are to work out: 1. Whether the two new treatments, cediranib-paclitaxel (Arm 2) and cediranib-olaparib (Arm 3) are more effective at controlling endometrial cancer than standard paclitaxel chemotherapy (Arm 1) 2. Whether the two new treatments cause more or fewer side-effects than standard chemotherapy 3. How each of these treatments impact on the daily life of women receiving the treatment by asking trial participants to regularly complete quality of life questionnaires 4. Whether we can learn how these treatments work in women with endometrial cancer by taking some additional blood tests for research.
NCT03570437 — Endometrial Neoplasms
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-neoplasms/NCT03570437/
Phase II Study of Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Stage I Endometrial Adenocarcinoma With Grade 2 Differentiation or Superficial Myomectomy Invasion
This registry aims to evaluate the efficacy of using high-dose oral progestin in young women with stage I endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasion as a fertility-sparing management.
NCT03567655 — Endometrial Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03567655/
A Randomized, Double-Blind, Phase 3 Trial of Maintenance With Selinexor/ Placebo After Combination Chemotherapy for Patients With Advanced or Recurrent Endometrial Cancer
This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.
NCT03555422 — Endometrial Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03555422/
Minimally and Non-invasive Methods for Early Detection and Progression of Endometrial Cancer
Endometrial cancer (EC) is the most frequent gynecological malignancy but there is currently lack of both non-invasive diagnostic tools and novel markers to stratify patients based on their risk of future recurrence. Patient care could be improved by advances in these two aspects. In the present study, the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and prognostic biomarkers for selection of patients with poor prognosis.
NCT03553589 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03553589/
Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?
Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer This study will examine the MRI features of women with confirmed endometrial cancer to see if textural features can prognosticate patients.
NCT03543215 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03543215/
Effect of Fertility-sparing Therapy of Early Endometrial Cancer
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
NCT03538704 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03538704/
The DETECT Study: Discovery and Evaluation of Testing for Endometrial Cancer in Tampons
Background: Endometrial cancer is a common and deadly cancer for women. It is getting more common and deadly because risk factors like age and obesity are increasing. It is highly curable if it is identified early. But there may be no symptoms early or they may be missed. Also, this cancer is becoming more common and deadly for black women than white women. Researchers want to find better ways to take samples and test them for this cancer. They want to study this for a racially diverse population. One way to take samples might be from a tampon. Objective: To see if it is possible and acceptable to collect an endometrial sample from women by using a tampon placed in the vagina. Eligibility: Women at least 45 years old who are having a hysterectomy Design: Participants will put a tampon in their vagina at least 30 minutes before their surgery. Participants will take a short survey. The tampon will be collected during the surgery. A small piece of tissue will be collected from the uterus that is removed in surgery. Participants will give a blood sample. Before or after surgery, participants will answer questions. These will be about their medical history and basic data such as age and race. Researchers will follow participants medical records for up to 3 years after the study. Researchers will study the samples and tampons. They will compare how well cancer and other markers are detected between the samples.
NCT03538665 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03538665/
A Phase II, Single Arm Study of Atezolizumab + Bevacizumab in Women With Advanced, Recurrent or Persistent Endometrial Cancer
This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of this drug combination will be assessed to see what effect this treatment has on this patient population.
NCT03526432 — Endometrial Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03526432/
MITO END-3: A Randomized Phase II Trial of Carboplatin+Paclitaxel Compared to Carboplatin+Paclitaxel+Avelumab in Advanced (Stage III-IV) or Recurrent Endometrial Cancer
This study aims to evaluate the safety and activity of the Avelumab in combination with Carboplatin-Paclitaxel in advanced or recurrent endometrial cancer
NCT03503786 — Endometrial Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03503786/
FESPET Study: Female EStrogen recePtor in Endometrial Cancer Treatment
Endometrial cancer is the most common gynecological malignancy in the western world and its incidence is expected to increase in the coming years due to obesity. Major treatment modalities include surgery, radiotherapy and chemotherapy. Hormonal therapy can be considered in primary treatment if other treatment modalities are not feasible and in treatment for recurrent disease. Hormonal treatment has shown to be more effective in endometrial cancers expressing estrogen (ER) and progesterone receptor (PR). Tumor heterogeneity frequently causes loss of expression of ER and PR in metastasis compared to primary tumors. The FES PET CT scan combines PET-CT scan with an estrogen tracer, thus allowing non invasive visualisation of estrogen receptor, even in patients with metastasis that are difficult to reach for biopsy. FES PET has been shown to relate well to ER expression and to treatment response in breast cancer. This study explores the feasibility of the FES PET scan in endometrial cancer patients.
NCT03489473 — Endometrial Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03489473/