View clinical trials related to Endometrial Cancer.
Filter by:In order to formulate strategies to improve adherence to best practice guidelines, as well as utilization of novel therapies, investigators must understand current practice patterns surrounding tumor genetic testing in endometrial cancer. The aim is to survey a representative sample of gynecologic oncologists who belong to the society of gynecologic oncology, via an email survey, to better understand current practices surrounding tumor genetic testing as well as determine if there have been any changes to practice since the publication of recent trials on the use of immune-checkpoint inhibitors in endometrial cancer.
This is a single centre, single arm, open label, preoperative window of opportunity study. Grade 2 endometrioid endometrial carcinoma patients awaiting surgery will be prospectively recruited to receive a pre-operative progestin therapy course. Therapy response will be histologically evaluated and correlated with clinical and molecular data by comparison of responders vs. non-responders pre- and post-treatment tumor samples.
This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.
Patients with FIGO stage III endometrial carcinoma often require multimodality adjuvant therapy to improve survival and recurrence rates; however, the optimal adjuvant therapy sequence is yet to be established. Several studies have tried to answer this question including RTOG 9708, PORTEC-3, and GOG 258. Collectively, these studies show that concurrent chemotherapy and radiation (chemoRT) with cisplatin followed by additional chemotherapy (CT) and CT alone are acceptable regimens. However, both strategies show that distant recurrence remains a problem when CT is delayed after RT, and local control is compromised without RT. We wish to prospectively assess outcomes of women with advanced endometrial carcinoma who receive concurrent chemoRT with a carboplatin/paclitaxel-based regimen. A total of 60 patients with FIGO stage III uterine carcinoma will be prospectively enrolled after undergoing surgical staging (currently accruing). CT will start approximately 4 weeks after surgery. Patients will receive 6 cycles of carboplatin (AUC 6) and paclitaxel (175 mg/m2). RT will be given during CT cycles 1-3. External beam RT will be given via intensity-modulated RT in once-daily fractions of 1.8-2.0 Gy for a total dose of 44-45 Gy to the pelvis (vaginal cuff, pelvic LN, and para-aortic lymph nodes). If there is grossly visible nodal disease seen at the time of treatment planning, a boost to 54 Gy will be given to those areas. If the patient has cervical stromal invasion, we will recommend that she receive a brachytherapy boost. Data will be collected on OS and PFS endpoints. Data will also be collected on provider- and patient-reported treatment toxicity. Patients will receive a series of questionnaires at baseline, 3, 6, 12, and 24 months after surgery. These are prospectively-validated questionnaires and include FACT-G, FACT-En, FACT/GOG-NTX, and FACT-C. For statistical analyses, continuous and categorical variables will be analyzed. Kaplan-Meier survival estimates will be calculated for local control and survival end points. For each patient, disease characteristics and adjuvant treatment will be placed in a simple logistic regression model for predicting survival endpoints. A multivariate analysis will be performed for exploratory purposes. Hazard ratios and 95% confidence intervals will be reported. Tests will be considered significant at p < 0.05.
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CYH33 in combination with olaprib in patients with DDR gene mutations and/or PIK3CA mutations, in patients who have progressed on prior PARP inhibitor, and in patients with recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer who are platinum resistant or refractory. The study will assess if this combination will optimize anti-tumor activity, block tumor growth and overcome the resistance to PARP inhibitor treatment. The study consists 2 parts. In Part 1 dose escalation, the objective is to determine the maximum toleration dose (MTD) of the combination. The final recommended phase 2 dose (RP2D) of CYH33 in combination with olaparib will be based on the totality of an overall assessment of available safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy which could be the MTD or a dose level lower in specific cohorts of patients. In Part 2 dose expansion, the main objective is to evaluate the efficacy at RP2D.
The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.
This is a a Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Multi-cohort Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination with MGD013 in Patients with Advanced or Metastatic Solid Tumor Who Failed Prior Treatment. This study consists of dose escalation part and dose expansion part.'3+3'design will be adopted in the dose escalation part in subjects with advanced or metastatic gastric cancer who failed prior treatment. The dose of niraparib will be fixed and determined based on baseline weight and platelet count of subjects. Dose expansion part will be expanded at the specified dose level to further assess the safety and preliminary antitumor activity.
Programmed cell death 1 (PD-1) inhibitor treatment may benefit patients with endometrial cancer (EC) based on the following observations: 1) an overwhelming presence of PD-1 in ECs; 2) the well-known effect of obesity which activates pro-inflammatory white blood cells and promotes the development of ECs; and 3) the high prevalence of a specific gene pattern (ie, microsatellite instability hypermutated [MSI high]) among ECs that may be particularly sensitive to this class of drugs. To identify potential biomarkers of response to PD-1 inhibitors in EC, we will conduct a window of opportunity study of pembrolizumab in 20 patients with clinical stage 1, grade 3 EC, encompassing endometrioid, serous and clear cell histologies. Eligible patients will undergo a research biopsy for collection of fresh tissue at the time of enrollment, in addition to the routinely performed endometrial biopsy that led to the diagnosis of their cancer. Patients will receive a single dose of pembrolizumab (200 mg IV) prior to undergoing their scheduled hysterectomy with surgical staging three weeks later. As per standard of care, adjuvant chemotherapy with paclitaxel and carboplatin will be recommended after hysterectomy/surgical staging for women with endometrioid tumors and stage III disease or women with serous/clear cell tumors at all stages of disease. However, in this study pembrolizumab will be added to adjuvant paclitaxel and carboplatin for EC. Pre-treatment endometrial biopsy specimens (fresh frozen tissue and formalin-fixed paraffin embedded (FFPE)) and a post-treatment hysterectomy specimen (fresh frozen tissue and FFPE) will be collected for translational studies. Blood, fecal and vaginal samples will be collected pre-treatment, at the time of surgery and following 3 cycles of adjuvant pembrolizumab/paclitaxel/carboplatin treatment.
The purpose of this single-arm phase II trial is to determine whether nicotinamide riboside (NIAGEN®) prevents the progression of peripheral sensory neuropathy in patients receiving infusions of paclitaxel or nab-paclitaxel for the treatment of metastatic breast cancer or recurrent platinum-resistant ovarian, endometrial, peritoneal, fallopian tube cancer or metastatic head and neck cancer.
This is a phase 1/phase 2a study of the combination of immune checkpoint inhibitor (nivolumab) in combination with the PARP inhibitor (rucaparib) for patients with metastatic castration resistant prostate cancer (mCRPC) and metastatic/recurrent endometrial cancer. In the phase 1 portion, the safety of the combination dosing will be determined. If the combination dosing is determined to be safe and feasible, the study will move onto phase 2a. In the phase 2a portion, participants will be randomized to receive either: rucaparib alone, nivolumab alone, or combination therapy (rucaparib and nivolumab).