Neoplasms

Digestive System Diseases

All Conditions

Carcinoma, Hepatocellular

Liver Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hematinics

All Drugs and Chemicals

Liver Extracts

The patient is placed in a supine position and standard laparotomy (either via subcostal, midline or inverted hockey-stick incision) is performed. After mobilization of the liver, surgical swabs are packed around the organ to prevent unnecessary movement of the liver during the acquisition of the landmarks and the subsequent surgical procedure

Abdominal surgery

Vanessa Banz, Dr. med.

Daniel Candinas, Prof. Dr. med.

Preoperative image-guided data correlates with the actual intraoperative reality. Computer-assisted preoperative planning combined with intraoperative mapping of even very small lesions allows for improved accuracy during complete oncological resection / ablation. In the short- and long-term this possibly results in better patient outcome.

Background

The aim of this study is to analyze the available accuracy of a computer-assisted approach to liver surgery and microwave ablation. The term 'computer-assisted' refers to 1) using 3D models of patient anatomy for extended orientation during the planning of the intervention and 2) using an image guidance system (similar to a GPS in a car) that allows for precise targeting of desired anatomical structures (e.g. intrahepatic tumor, bile ducts / vasculature) in the setting of successfully treating liver malignancies. Furthermore, we would like to demonstrate, that image guided open liver surgery is technically feasible, whenever the correlation between preoperative image-guided data and the intraoperative setting can be achieved with a known accuracy.

Eventually, this technology, like in other surgical domains, will lead to successively implemented technical guiding functionalities that could potentially improve patient outcome.

Objective

To date, first systems (CE marked medical devices) are available that have been specifically developed for image-guided open liver surgery. The systems tracks positions of surgical instruments in or near the target organs and visualizes the instruments position in correlation to patients medical image data (i.e. 3D-CT) on the computer screen. Surgeons benefit from a view to a virtual scene (on a computer screen) in which CT images, together with models of the vascular structures, tumors and organ boundaries, are intuitively visible. The surgeon can see the moving instrument, just like the movement of a car can be seen in a GPS system

Methods

In patients requiring extensive surgery (eg. extended right hemihepatectomy), accurate calculations of the remaining liver volume are essential to avoid postoperative liver failure with potentially serious postoperative complications or even death, resulting from an inadequate remaining liver volume (ie "small-for-size syndrome"). In high-risk liver resections, use of computer programs, such as MeVis (MeVis Medical Solutions Inc.), provide the surgeon with accurate preoperative information, allowing him / her to judge the feasibility of the planned surgical resection based on preoperative liver volume analysis and evaluation of the planned resection line in relation to essential structures (ie. major vessels / bile ducts).

Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver

Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver: A Prospective, Non Randomized Study

Insel Gruppe AG, University Hospital Bern

Dr.med. Vanessa Banz/ Prof. Dr. med.Daniel Candinas

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Menopause

CBT and relaxation

Physical activity

Group AB: Combined CBT and exercise program. Women assigned to Group AB will undergo the CBT and exercise elements of the program concurrently. To as great an extent as possible, the on-site CBT and in-clinic exercise training sessions will be scheduled on the same day.

CBT and physical activity

Control group

Saskia Duijts, PhD

Neil Aaronson, Prof

Background: Breast cancer is the most common form of cancer among women in the Netherlands. Approximately 11,000 women are diagnosed with breast cancer annually, of whom about 30% are below 50 years of age. Premenopausal women with breast cancer treated with chemotherapy or hormonal therapy may experience a premature onset of the menopause. Estrogen deficiency following adjuvant treatments leads to primary endocrine symptoms, including vasomotor and urogenital problems. Secondary symptoms include insomnia due to night sweats, dyspareunia due to vaginal dryness, weight gain, and psychological distress. The symptoms resulting from accelerated estrogen withdrawal can be pronounced and severe, and may adversely affect women's sexual functioning, body image, and overall HRQL. Healthy women who enter natural menopause are often prescribed hormone replacement therapy (HRT) to alleviate vasomotor and sexual symptoms. However, due to possible tumor-promoting effects, HRT is contraindicated for patients with a history of breast cancer. For these women, non-hormonal medications are frequently prescribed to treat vasomotor symptoms. Although these medications have been shown to yield moderate symptom relief, they also have a number of bothersome side effects. To alleviate urogenital symptoms, local vaginal moisturizing or estrogen cream is often prescribed. There is growing evidence that cognitive behavioral therapy (CBT) including relaxation techniques, and physical exercise may effectively reduce vasomotor symptoms in naturally occurring menopause. CBT and relaxation techniques are aimed primarily at the modification of precipitants of hot flushes and at stress management. Physical exercise on a regular basis affects neurotransmitters, which regulate central thermoregulation.

Purpose: The proposed study will evaluate the efficacy of a supportive intervention program in alleviating menopausal symptoms, improving sexual functioning and enhancing the quality of life of younger women (\< 50 years) with breast cancer who have become prematurely menopausal as a result of their treatment. Specifically, the study will evaluate CBT including relaxation (A), physical exercise (B), and a combination of A and B.

Plan of investigation: This multicenter study will employ a prospective, full-factorial design. In total, 325 consenting women will be randomized to group A, group B, group AB or a usual care, 'waiting list' control group (N = 81-81 per group). Upon completion of the study, the patients assigned to the control group will be given the opportunity to undergo either the A or B intervention program. The program will begin with a structured assessment of the target symptoms: hot flushes, night sweating and vaginal dryness. The overriding goal of the intervention is to provide symptomatic women with information skills and support to manage their symptoms more effectively. For group A, the intervention will consist of 6 weekly group CBT sessions of 1.5 hours, of 15 minutes of daily homework and a booster session at 3 months. The CBT will focus on understanding and self-control of menopausal symptoms. Relaxation techniques (paced respiration and muscle relaxation) will focus on the reduction of sympathetic nervous system activity, and are expected to have a positive impact on the frequency and intensity of hot flushes. For group B, the intervention will be an individually tailored, 12 week home-based physical exercise program of 2.5-3 hours per week, with instructions provided in-clinic on 2 occasions, and telephone support on 2 additional, interim occasions. The physical exercise program is intended to enhance fitness levels, in general, and to improve thermoregulation specifically related to hot flushes. Group AB will receive both the CBT and exercise program elements. Women allocated to the intervention groups will be asked to complete a battery of questionnaires assessing menopausal symptoms (the primary outcome), sexuality, body- and self-image, psychological distress and generic HRQL prior to the start of the program (baseline, T0), at 12 weeks (T1) and at 6 months follow-up (T2). Women allocated to the control group will complete the same questionnaire battery at parallel points in time.

Results/ relevance: If demonstrated to be effective, the availability of a structured supportive intervention program (modules A, B or AB) will be a welcome addition to regular medical care offered to breast cancer patients with treatment-induced menopause. It is anticipated that such a program will have direct benefit in terms of symptoms relief and the improvement of patients' HRQL.

Cognitive Behavioral Therapy (CBT) and Physical Exercise for Climacteric Symptoms in Breast Cancer Patients Experiencing Treatment-Induced Menopause: a Multicenter Randomized Trial

Dutch Cancer Society

The Netherlands Cancer Institute

Prof. dr. N.K. Aaronson

Symptoms and General Pathology

Neoplasm Metastasis

Head and Neck Neoplasms

Antineoplastic Agents

Cetuximab

400mg/day with 2 doses of 200mg 12-hour apart For each 28-day cycle, a total of 56 doses of study drug will be dispensed.

Route of administration : oral

Duration of treatment until the patient experiences an unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

Abemaciclib

Jérôme FAYETTE, MD

This trial is an open-label, single arm, Phase II study using an A'Hern single stage design.

The molecular prescreening step will allow to defined HPV tumor status as well as molecular status CDKN2A, CCND1 and CDK6. Following this centralized molecular screening, only patients with HPV negative status and with tumor harboring CDKN2A homozygous deletion and/or CCND1 amplification and/or CDK6 amplification could initiate abemaciclib at time of documented radiological progression. Patients will be treated with ABEMACICLIB, 400 mg/day with 2 doses of 200 mg 12 hour apart (QH12). A cycle is defined as an interval of 28 days. For each 28-day cycle, a total of 56 doses of study drug will be dispensed.

SAMPLE SIZE DETERMINATION The primary endpoint is the non-progression rate (CR, PR, SD as per RECIST 1.1) after 8 weeks of treatment.

The sample size calculation was based on an A'Hern single stage phase II design, with a minimum success (non- progression) rate considered of interest of p1=40% and an uninteresting rate of p0=15%. Assuming a type I error alpha of 0.05 and 85% power, 23 patients are needed to reject the null hypothesis H0: p\<=p0 vs the alternative hypothesis H1: p ≥ p1 in a unilateral situation.

Based on the assumption that 10% of the patients may be non-evaluable, 25 patients will be included in the study.

DATA ENTRY AND DATA MANAGEMENT All the data concerning the patients will be recorded in the eCRF throughout the study. SAE reporting will be paper-based by Fax.

The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol, Good Clinical Practices (GCP) and local low requirements.

Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6

A Phase II Trial Aiming to Evaluate the Clinical Interest of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6

Objective response rate after 8 weeks is defined as the proportion of patients with complete or partial response after 8 weeks of treatment according to RECIST 1.1.

The Duration of Response (DoR) will be measured from the time of first documented response (CR or PR as per RECIST 1.1) until the first documented disease progression or death due to underlying cancer, or censored at the date of the last available tumor assessment

The Time to Progression will be measured from the time of treatment start until the first documented disease progression

The Time to treatment failure will be measured from the time of treatment start until discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death

Progression-Free Survival (PFS) will be measured from the date of inclusion until the date of event defined as the first documented progression or death from any cause. Patients with no event at the time of the analysis will be censored at the date of the last available tumor assessment. PFS will be estimated using the Kaplan-Meier method

Overall survival will be measured from the date of treatment start to the date of death from any cause

Centre Leon Berard

Nutritional and Metabolic Diseases

Musculoskeletal Diseases

Rare Diseases

Obesity

Craniopharyngioma

Adamantinoma

Ameloblastoma

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Bone Neoplasms

Bone Diseases

Hypothalamic Obesity

Neuroepithelioma

Gastrointestinal Agents

Hypoglycemic Agents

Anti-Obesity Agents

Glucagon

Glucagon-Like Peptide 1

Exenatide

Glucagon-Like Peptide-1 Receptor Agonists

Incretins

Hormones

Hormone Antagonists

Treatment with exenatide at the initial dose of 5 µg x 2/day (subcutaneously administered) during 4 weeks, and treatment with 10 µg x 2/day during 5 months.

Patients will be maintained on placebo (injected subcutaneously, twice a day) with the same dose and frequency than exenatide arm.

Placebo

Paul Perez, Dr

Blandine Gatta-Cherifi, Pr

This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.

The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.

The development of glucagon-like peptide-1 (GLP-1) analogues might be a solution since native GLP-1 suppresses appetite and energy intake in both normal weight and obese individuals as well as in people with type 2 diabetes and delays gastric emptying. The underlying mechanisms that mediate the effects of weight involve not only central regions like the hypothalamus and the solitary tractus nucleus and area postrema but also peripheral regions as the gastrointestinal tract. These extra hypothalamic effects are of particular interest in the cases of obesity due to hypothalamic lesions.

Exenatide is a glucagon-like peptide-1 (GLP-1) analogue with a high structural homology to human GLP-1, a gut derived incretin hormone. Since exenatide causes a dose-dependent weight loss, decreasing concentration of glycosylated haemoglobin as well as improving ß-cell function and systolic blood pressure, it could be an attractive treatment for both type 2 diabetes and obesity. In a double-blind placebo-controlled 24-week trial, it has been recently shown that non diabetic obese patients maintained on exenatide 10µg x 2/j lost significantly more weight than did those on placebo (5.1 kg versus 1.6).

Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

The primary outcome will be assessed by a weighing machine that measure until 200 kg.

Tolerance will be assessed by the presence of:

- Nauseas, vomiting.

Tolerance will be assessed by the presence of:

- Injection-site symptoms.

Tolerance will be assessed by the presence of :

- Increasing of pulse rate.

Tolerance will be assessed by the presence of :

- Anxiety by Beck scale.

Tolerance will be assessed by the presence of :

- depression evaluated by HAD scale.

Tolerance will be assessed by the presence of :

- Increasing of pancreatic enzymes.

Tolerance will be assessed by the presence of :

- Hypoglycaemia

Levels of blood glucose and insulin, oral glucose tolerance testing, haemoglobin A1C

Levels of HDL cholesterol, triglycerides, LDL cholesterol.

The metabolic parameters considered:

- Body composition (Dual energy-ray absorptiometry) and abdominal obesity (waist circumference).

The eating behaviour will be evaluated by:

- Plasma level of ghrelin measured after an overnight fast.

The eating behaviour will be evaluated by:

- Scores of restriction, hunger and disinhibition (French version of the Three factor Eating Questionnaire).

The eating behaviour will be evaluated by:

- Scores of desire to eat, hunger and fullness at visual analogic scales.

The quality of life will be assessed by:

- Scores of depression (short questionnaire of Beck).

The quality of life will be assessed by:

- Scores of quality of life (ORWELL questionnaire).

The energy expenditure will be estimated thanks to pedometer.

- Resting metabolic rate (indirect calorimetry).

The energy expenditure will be estimated thanks to:

- Resting metabolic rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver	NCT01474694	Adult Liver Can...	Abdominal surge...	18 Years -	Insel Gruppe AG, University Hospital Bern
Cognitive Behavioral Therapy (CBT) and Physical Exercise for Climacteric Symptoms in Breast Cancer Patients Experiencing Treatment-Induced Menopause: a Multicenter Randomized Trial	NCT00582244	Menopausal Symp...	CBT and relaxat... Physical activi... CBT and physica... Control group	30 Years - 50 Years	The Netherlands Cancer Institute
Cognitive Behavioral Therapy (CBT) and Physical Exercise for Climacteric Symptoms in Breast Cancer Patients Experiencing Treatment-Induced Menopause: a Multicenter Randomized Trial	NCT00582244	Menopausal Symp...	CBT and relaxat... Physical activi... CBT and physica... Control group	30 Years - 50 Years	The Netherlands Cancer Institute
Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6	NCT03356223	Head and Neck C... Advanced Cancer Metastatic Canc...	Abemaciclib	18 Years -	Centre Leon Berard
Accuracy Assessment for Computer-assisted Surgical Interventions of the Liver	NCT01474694	Adult Liver Can...	Abdominal surge...	18 Years -	Insel Gruppe AG, University Hospital Bern
Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy	NCT02860923	Craniopharyngio... Hypothalamic Ob...	Exenatide Placebo	18 Years - 75 Years	University Hospital, Bordeaux

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