Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue (ISB) and Indocyanine Green Dyes (ICG) With Fluorescence Imaging
The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H&E pathologic analysis.
NCT02068820 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT02068820/
A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer
This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.
NCT02065687 — Endometrial Adenocarcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-adenocarcinoma/NCT02065687/
Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients
Purpose: This is an open label, single-arm, single-center study of the addition of metformin to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1 endometrial adenocarcinoma (EC; n=15). Participants:Women, over the age of 18 years, with biopsy-proven CAH/EC who are not candidates for surgical management, and therefore are planned to start standard of care treatment with the LR-IUD Procedures (methods): subjects will be given oral metformin therapy for 12 months, or until disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial endometrial biopsies will be performed, as per standard of care, to assess disease status.
NCT02035787 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT02035787/
A Phase II Head-to-Head Comparison of Fertility-Sparing Approaches to Treat Complex Atypical Hyperplasia of the Edometrium: Megestrol Versus Levonorgestrel-Releasing Intrauterine System (LNG-IUS)
This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial hyperplasia or endometrial cancer.
NCT01943058 — Endometrial Adenocarcinoma
Status: Withdrawn
http://inclinicaltrials.com/endometrial-adenocarcinoma/NCT01943058/
A Phase II Clinical Trial of Adjuvant Postoperative Irradiation Combined With Paclitaxel/Carboplatin(TP) or Cisplatin/Doxorubicin/Cyclophosphamide (CAP) Chemotherapy for Patients With High-risk Endometrial Cancer
This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.
NCT01918124 — Prosthesis Survival
Status: Completed
http://inclinicaltrials.com/prosthesis-survival/NCT01918124/
Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for High Risk Endometrial Cancer
This clinical trial studies positron emission tomography (PET)/computed tomography (CT) and lymph node mapping in finding lymph node metastasis in patients with endometrial cancer that is at high risk of spreading. A PET/CT scan is a procedure that combines the pictures from a PET scan and a CT scan, which are taken at the same time from the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. Lymph node mapping uses a radioactive dye, called indocyanine green solution, to identify lymph nodes that may contain cancer cells. PET/CT and sentinel lymph node mapping may be better ways than surgery to identify cancer in the lymph nodes.
NCT01737619 — Endometrial Serous Adenocarcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-serous-adenocarcinoma/NCT01737619/
Prospective Randomized Trial on Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Endometrial Cancer FIGO Stage IB-II: Thunderbeat Technology Versus Standard Bipolar Electro-surgery.
This prospective randomized pilot study is aimed to verify if the operative time of a TLH with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery . Secondary endpoints of this comparison are incidence of intra- or postoperative complications (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.
NCT01717794 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT01717794/
Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery
Endometrial and cervical cancers are one of the most common malignancies seen in females. Identification of recurrent disease in early phases of treatment carries a primary importance on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new technique recently started to be performed in body imaging and has potential ability to detect recurrent disease. The aim of this study is to investigate the diagnostic impact of DWI in detection of recurrent disease in patients treated with curative surgery in endometrial and cervical cancer.
NCT01710085 — Cervical Cancer
Status: Recruiting
http://inclinicaltrials.com/cervical-cancer/NCT01710085/
A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer
A 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.
NCT01686256 — Ovarian Cancer
Status: Completed
http://inclinicaltrials.com/ovarian-cancer/NCT01686256/
Phase I/IIa Trial of Folate Binding Protein (FBP) Peptide (E39) Vaccine in Ovarian and Endometrial Cancer Patients
Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The purpose of this study is to test whether a peptide-based vaccine consisting of the E39 peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune response. Furthermore, the investigators intend to determine the best dose of the vaccine to utilize to produce this immunity most efficiently. The investigators will determine whether immunity to FBP will prevent clinical recurrence. Additionally, the investigators will compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu protein) in ovarian and endometrial cancer patients in preparation for studying a combination vaccine.
NCT01580696 — Ovarian Cancer
Status: Completed
http://inclinicaltrials.com/ovarian-cancer/NCT01580696/