POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus
CarcinomaEndometrioid1 moreType of Application: Clinical trial of new indication. Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09. Primary Objective: To identify in tumor samples future biomarkers associated with a short term exposure to temsirolimus. This is an exploratory clinical study. No efficacy objectives are included in this clinical trial. Secondary Objectives: To estimate the tolerability for all temsirolimus-treated patients throughout the study and up to 28 days after the last dose of temsirolimus. To correlate observed changes with the different type of endometrial carcinoma (type I and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D, p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR), To estimate the potential predictive value of some biomarkers (immunostaining for PTEN, pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite instability status. To estimate the prognostic value of Ki67 expression after short-term presurgical therapy exposure To collect data about the differences in expression profile, assessed by RNA microarrays
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial...
Ovarian CancerEndometrial CancerA Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer. Phase I - The proposed indication for FolateScan is disease or pathological assessment of ovarian or endometrial masses.
Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis...
Cervical CancerColorectal Cancer10 moreRATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is effective for diarrhea. PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.
Identification and Characterization of Ovarian Cancer and Endometrial Cancer Specific Biomarkers...
Cancer of OvaryThe purpose of this study is to: Identification and characterization of ovarian carcinoma well-known biomarkers, carcinoma antigen 125 (CA125) and Human epididymis protein 4 (HE4) and other potential biomarkers in vaginal fluids obtained from ovarian cancer patients. Quantification and calibration of identified biomarkers in vaginal discharge collected from ovarian cancer patients in comparisons to samples collected from healthy volunteers. Comparison analysis of biomarkers levels in vaginal fluids vs. serum. Quantification and calibration of identified biomarkers in vaginal discharge collected from ovarian cancer patients diagnosed in various stages.
CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated...
NeoplasmsLung Neoplasms23 moreRegistry participants with advanced malignancy or myelodysplasia will have a sample of their tumor or tissue analysed for genetic alterations using next generation sequencing (NGS) performed in a lab that has been certified to meet a high quality standard. Treatments and outcomes will be reported to the registry to allow further understanding of how genetic differences can lead to better diagnosis and treatments.
A Phase II of Nivolumab Plus Ipilimumab in Non-resectable Sarcoma and Endometrial Carcinoma
Soft Tissue SarcomaBone Sarcoma6 moreThe purpose of this study is to determine whether nivolumab plus ipilimumab are effective and safe in the treatment of sarcoma and endometrial carcinoma patients with somatic deficient MMR as a selection tool.
Adjuvant Protontherapy of Cervical and Endometrial Carcinomas
Uterine Cervical NeoplasmsEndometrial Neoplasms MalignantThe APROVE study is a prospective single-center single-arm phase-II study. Patients with cervical or endometrial cancer after surgical resection who have an indication for postoperative pelvic radiotherapy will be treated with proton therapy instead of the commonly used photon radiation. A total of 25 patients will be included in this trial. Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation. Platinum-based chemotherapy can be administered if indicated. The primary endpoint of the study is the evaluation of safety and treatment tolerability of pelvic radiation using protons defined as the lack of any CTC AE Grade 3 or 4 toxicity. Secondary endpoints are clinical symptoms and toxicity, quality of life and progression-free survival. The aim is to explore the potential of proton therapy as a new method for adjuvant pelvic radiotherapy to decrease the dose to the bowel, rectum and bladder thus reducing acute and chronic toxicity and improving quality of life.
Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial...
Endometrial CancerPrimary objective To discover the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin, as fertility-preserving treatment for grade 1 endometrioid adenocarcinoma of endometrium, cT1aN0M0 with presumed no myometrial invasion on image study (MRI preferred). Secondary objectives To discover the morphological and molecular change in the endometrium tumor before and after treatment To discover the effectiveness of adding oral progestin to subjects who show no good response to assigned To compare (1) the systemic effects, including body weight change, neuropsychiatric alternation, GI disturbance, skin disorder, change in serum metabolic and hepatic markers between the two study patient groups; (2) The rate of long-term success defined as (a) sustained remission of >= 12 months starts from the histologic documentation of complete remission (b) rate of pregnancy and (c) alive baby delivery, based on time-to-event analysis. Molecular markers and their expression before, during and after treatment, including progesterone B receptor, progesterone A receptor, estrogen receptor, Ki67, PTEN and its related markers, Bcl2 and its related markers and other developing markers. This is to discover prediction markers to medical treatment.
Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer...
Endometrial CancerThis 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.
Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer
Endometrial NeoplasmsUterine Neoplasms1 moreThe DOMEC trial is designed as a Dutch Gynecological Oncology Group (DGOG), prospective, multi-center, phase II study for 55 patients with advanced (recurrent, refractory or metastatic) endometrial cancer or carcinosarcoma of the uterus to investigate the efficacy of the combination therapy of olaparib tablets and durvalumab IV.