Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted...
Cervical CancerUterus Cancer1 moreThe purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.
The Hysteroscopic Morcellator (HM).
Large Intrauterine PolypsSmaller Type 0 and 1 Myomas1 moreRationale: The hysteroscopic morcellator (HM) is a novel technique for removal of intrauterine polyps, myomas and placental tissue. It withholds some technical advantages over resectoscopy. Previous data suggest that it's a faster technique than the latter, and shows that it has a low complication rate. Objective: To compare the HM to bipolar resectoscopy for removal of: 1) large intrauterine polyps, 2) smaller type 0 and 1 myomas, 3) residual placental tissue, in terms of efficiency and complications. Study design: Single blind, randomized controlled multicenter trial. Study population: Women aged over 18 years old with: 1) large (≥ 1 cm) intrauterine polyps, 2) smaller (≤ 3 cm) type 0 or 1 myomas, 3) residual placental tissue, who are planned for hysteroscopic removal. Intervention: Patients are randomized between removal with the HM or the bipolar resectoscope. Main study parameters/endpoints: Installation and operating time. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Women who are referred to our polyclinic will be seen on a first visit, and, according to the standard work-up, an ultrasound will be performed when intrauterine pathology is suspected. To confirm the diagnosis a saline infusion sonography (SIS) and/or ambulant diagnostic hysteroscopy will be performed consequently. Once the diagnosis is confirmed and surgery is planned, women will be asked whether they want to take part in this study. At this moment, both techniques are used in our hospitals and the choice of treatment depends on the preference of the gynaecologist. All women will be treated with operative hysteroscopy in a daycare setting according to the standard of care, only now randomized between the two techniques. A standard postoperative visit with ultrasound examination and/or ambulant diagnostic hysteroscopy is scheduled 6 weeks later. Late postoperative complications and complaints are recorded. It is expected that the HM beholds some advantages over the bipolar resectoscope such as shorter operating time and less complications (e.g. risk of perforation, current and fluid related complications). Previous data do not demonstrate any additional risks related to the use of the HM. Moreover we will check whether the HM has a lower risk of intrauterine adhesion formation, as this might influence patient's fertility. After completion of the RCT, an observational study is planned considering pregnancies subsequent to the hysteroscopic procedure.
Magnetic Resonance Imaging Guided Gynecologic Brachytherapy
Cervix NeoplasmsUterine Neoplasms2 moreThe primary goal of this pilot study is to assess the feasibility of using magnetic resonance (MR) imaging guidance in the Magnetic Resonance Therapy (MRT) unit at the Brigham and Women's Hospital during the implantation of brachytherapy applicators in patients with gynecologic malignancies. Patients with gynecologic malignancies requiring brachytherapy are currently treated under either fluoroscopic or CT visualization of the brachytherapy applicator. Magnetic resonance imaging has been shown in many studies to provide superior visualization of the cervix, vagina and uterus compared to CT. However no prior study has examined the feasibility of using real-time magnetic resonance imaging to assist in the guidance of gynecologic brachytherapy applicators
A Trial for Patients With Gestational Trophoblastic Disease
Trophoblastic NeoplasmsUterine Neoplasms2 moreThis phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients...
Low Anterior Resection SyndromeMalignant Anal Neoplasm9 moreThis phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.
A Pilot Study of Celecoxib in Patients With Grade 2 or 3 Uterine Cancers
Uterine CancerExpression of COX-II has been identified in many types of human cancers. Uterine cancer is the most common gynecologic cancer in the US and there has been an increase in uterine cancer deaths over the past decade mainly due to the difficulty in treating recurrences in the more aggressive histologic types. The study co-investigators have also identified COX-II expression in grade 2 and 3 endometrioid-type, clear cell, and papillary serous types of uterine cancers. Upregulation of COX-II may control the cell cycle by regulating the proliferative capacity of neoplastic endometrial cells. This is a Phase II pre-post intervention comparison study in eligible patients looking at the effects of a COX-II inhibitor on uterine cancer. The patients whose endometrial biopsy shows grade 2 or 3 endometrioid-type, clear cell, and papillary serous types of uterine cancers will be put on a selective COX-II inhibitor, Celebrex (Celecoxib) until the day of their surgery. We hypothesize that Celecoxib will downregulate the expression of COX-II in these tumor types as it does in other similar tumors. We also hypothesize that apoptosis, as measured with the TUNEL assay, will be increased in areas with less COX-II expression and should be inversely proportional to cellular p21 expression. We hypothesize COX-related gene expression will be altered thus suggesting an up- or down-regulation of these genes in the end-organ tissue. Documenting downregulation of COX-II enzyme and altered gene expression in endometrial carcinoma after treatment with Celecoxib may result in further prospective studies using selective COX-II inhibitors as effective, well-tolerated chemotherapeutic agents in these uterine cancers that are resistant to many current therapies.
Comparison of Standard of Care or Treatment on Protocol
Stomach CancerEsophageal Cancer5 morePatient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion.
Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography...
Cervical CancerHEENT Cancer4 moreThe purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor. These low oxygen areas are thought to be the reason why tumors are more resistant to radiation treatment. A tracer is an extremely small quantity of a substance. Tracer to which radioactivity has been attached may be used to "trace" events in the body. A tracer called iodo-azomycin galactopyranoside (or *IAZGP) appears to be able to detect low oxygen areas within tumor. Radioactive iodine in this molecule can be detected by an imaging technique called a PET scan. This present study involves obtaining three scans using this new imaging technique. The goal of carrying out many scans is to determine which scan will best show any areas in your tumor that may have low levels of oxygen.
Strength Training Study for Survivors of Breast and Gynecologic Cancer
Breast CancerGynecologic Cancer3 moreThe purpose of this study is to compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription.
Insights Into Participating in Studies for Uterine Cancer
Uterine CancerClinical study participation has historically been heavily biased toward specific demographics. Several people will be invited to enroll in this trial so that it may collect a variety of data about uterine cancer clinical study experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. People with uterine cancer who are invited to take part in medical study will benefit from the analysis of the data.