Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II
Endometrial CancerAdjuvant radiotherapy (RT) plays an important role in reducing the risks of local recurrence after surgery in uterine cancers. Standard adjuvant pelvic radiation treatment targets the pelvic lymph nodes, the post-operative bed, and the upper vagina and is typically treated with intensity modulated radiation therapy (IMRT) which has been shown to improve patient reported gastrointestinal (GI) and genitourinary (GU) toxicities. Although pelvic radiation has been shown to be effective at decreasing locoregional recurrences, patient quality of life and experience can be significantly impacted as pelvic RT comprises of daily radiation for 25 daily treatments, which can be a substantial burden on patients with this disease. Hypofractionated radiotherapy to a dose of 30 Gy in 5 fractions (6 Gy given every other day) for adjuvant radiation treatment in uterine cancer is hypothesized to result in similar rates of acute gastrointestinal toxicities as conventional fractionated radiation.
A Pilot, Open-label Study of 18F-Fluciclatide PET/CT Imaging in the Evaluation of Anti-angiogenic...
Colon CancerLung Cancer3 moreBackground: Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which preferentially binds with high affinity to alpha(v)beta(3) integrins, which are up-regulated in and may regulate angiogenesis. [18F]Fluciclatide is a new radiopharmaceutical developed for PET imaging Changes in [18F]fluciclatide uptake will be evaluated before and after treatment of patients with targeted antiangiogenic drugs Objectives: Primary To determine tumor uptake and retention of [18F]fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy Secondary To assess the safety of multiple intravenous (IV) administrations of Fluciclatide [18F] Injection in subjects with solid tumors To obtain preliminary data on the relationships between [18F]fluciclatide as a pharmacodynamic marker and standard of care imaging markers of clinical response (e.g. contrast-enhanced (CE) static computed tomography (CT), bone scintigraphy, FDG-PET), obtained as part of routine clinical follow-up as specified in the referring protocols, as well as any optional imaging performed Eligibility: Patients greater than or equal to 18 years, with documented malignancy, and solid tumor greater than or equal to 1 cm outside of the liver, who are scheduled to enroll in an NCI therapy protocol using one of the anti-angiogenic agents described in the full protocol Platelet count greater than 75,000 x 10(6)/L, hemoglobin greater than 9g/dL, prothrombin time (PT) and aPTT less than 2 times normal limits. The subject has not received any targeted anti-angiogenic agents within 60 days prior to pre-treatment (baseline) [18F]fluciclatide administration Design: This study is intended to obtain preliminary data on the uptake and retention of [18F]fluciclatide before and after anti-angiogenic therapy. This will enable optimization of the imaging protocol, identification of the most relevant imaging parameters, and allow for calculation of the number patients required to power a larger study to assess the utility of PET imaging with [18F]fluciclatide as a pharmacodynamic biomarker in the context of targeted anti-angiogenic therapies. We expect to enroll 30 evaluable patients in this single center study. Subjects will undergo at least two [18F]fluciclatide PET/CT imaging studies, one pre-therapy and one following completion of 1 cycle of chemotherapy. An optional early post-therapy (2-7 days post therapy commencement) [18F]fluciclatide PET/CT may be performed. The magnitude of [18F]fluciclatide uptake on the pre- and post- treatment PET/CT studies will be evaluated to determine if there is a measureable difference in uptake. Data from the subject's referring therapy protocol will be reviewed for up to one year. An optional DCE-MRI scans of the target lesion may also be performed.
Clinical Study of PD-1 Monoclonal Antibody SHR-1210 and Apatinib in Advanced NSCLC, Soft Tissue...
Advanced Non Small Cell Lung CancerUterine Cancer1 moreIn this one-arm study, histologically or cytologically confirmed advanced NSCLC, uterine malignancies, and soft tissue sarcoma will be enrolled to investigate the efficacy and safety of PD-1 monoclonal antibody SHR-1210 and apatinib, at the same time, peripheral circulating blood tumor cells (CTC) detection and CTC-based PD-L1 antibody immunofluorescence detection will be performed.
Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer
Stage III Ovarian CancerStage IV Ovarian Cancer1 moreThe purpose of this study is to determine the maximum tolerated dose (MTD) of the investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators intend to study the safety and tolerability of the study treatment, response to treatment, time to disease progression, and overall survival.
Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix
Uterine CancerCervical CancerProton beam radiation therapy is known to spare surrounding normal tissues from radiation. Proton beam radiation delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy which tends to unavoidably include more normal tissue along with tumor target tissue. In this research study, the investigators are looking to determine if proton beam radiation is effective in controlling your cancer growth. The investigators are also looking to see if proton beam radiation can reduce side effects when compared to standard radiation treatment (photon radiation).
Prospective Analysis of Robot-Assisted Surgery
Esophageal CancerGastric Cancer8 moreThe robot-assisted surgery allows three-dimensional view, detailed access of small structures, depth perception and articulated movements with wide latitude. Thinking about the inclusion of this branch of surgical outcome ICESP encouraged the training of their doctors and other health professionals , and has three tutors in the area of robot- assisted laparoscopic surgery , and various medical clinical staff , already trained , and already perform the procedure in other centers . The da Vinci ® Surgical System ( only existing in the World market) , consisting of one or two consoles for the surgeon and a tutor if necessary was adopted. Ergonomically designed, a stand next to the patient , with four interactive robotic arms , one of them , a vision system for high performance and the other three for exclusive EndoWrist ® instruments . Driven by the latest robotic technology , computer programs , frictionless transmission of manual controls , movements in scale and filtered made by the surgeon in the da Vinci ® System console are translated into precise movements of the instruments EndoWrist ® For surgeons , the da Vinci ® System offers superior 3D viewing with larger surgical precision ergonomic comfort and dexterity . For hospitals , the da Vinci ® Surgical System enables clinical and economic benefits of minimally invasive surgery are applied to a broader base of patients cirúrgicos.The main objective is to evaluate the safety and effectiveness of robotic surgery in the surgical treatment of cancer in operations below, as their specialties : Digestive , Urology , Gynecology , Head and Neck and Thorax . This is a prospective study lasting 36 months , where 1120 patients with surgical diseases in programming for the following operations will be studied : transthoracic esophagectomy ; subtotal gastrectomy with lymphadenectomy ; partial pancreatectomy ; resection of the rectum ; prostatectomy ; cystectomy ; partial nephrectomy ; hysterectomy with or without pelvic and paraaortic lymphadenectomy ; resection of malignant tumors of the mouth and orofaringolaringe and lung lobectomy . Patients will come from the outpatient services of the Institute of Cancer of São Paulo - ICESP
Developing a Stepped Approach to Improving Sexual Function aFteR Treatment fOr gyNaecological Cancer...
Cervical CancerOvarian Cancer4 moreWomen affected by gynaecologic cancers are often not aware of sexual consequences of cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the impact on their sexuality may be profound. Despite this several potential therapies can be effective in helping recovery. A major challenge is informing and involving the patients in an appropriate and sensitive manner, and a further issue is the delivery of such therapies in busy and medically driven gynaecologic oncology clinics. It will use and adapt existing evidence based therapies for improving sexual function after cancer treatment and develop a model for delivering these in the NHS (United Kingdom National Health Service) setting. The model of 'stepped care' is adapted from that used nationally and successfully in the Increasing Access to Psychological Therapies (IAPT) programme. Assessment allows for 'stepping up and down', i.e. calibrating the type of help a woman receives according to need and her response to treatment already given.This study will develop and evaluate a 'stepped' system of interventions using elements of best available evidence, adapting existing interventions to help women recover their sexual feelings and activity, starting with simple methods, moving on to new talking treatments for more complex cases. The investigators address all gynaecologic cancers on the principle that sexual difficulty is the problem the investigators are treating, not the cancer of origin. Ongoing clinical assessment will be vital for the success of the stepped care model. The investigators will deliver training and supervision to enhance the skills needed by the Clinical Nursing Specialist (CNS). An important part of this study will be characterising the range of women and their willingness to participate in psychosexual help. One-to-one follow up interviews will inform the level of input required for any subsequent Randomised Control Trial (RCT). The investigators will use internationally recognised rating scales for rating sexual function, assess how illness and treatment affect mood and self esteem. The investigators will also measure the overall cost-effectiveness to the public sector of providing this treatment, compared to costs of subsequent use of health and social services. This pilot study will assess the feasibility of conducting a full scale investigation of a stepped therapy and indicate the potential benefits to the patients, their partners, and to the NHS generally.
ChemoFx® PRO - A Post-Market Data Collection Study
Ovarian CancerFallopian Tube Cancer6 moreThis study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.
Endometrial Polyps Regression With Progesterone Therapy
Endometrial PolypThis prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle
Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures...
Ovarian CancerFibroids1 moreThe purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.