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NCT ID: NCT02072733 Completed - Cancer Clinical Trials

Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark

Start date: January 2015
Phase: N/A
Study type: Interventional

A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict complications to cancer treatment within a three months period.

NCT ID: NCT02069743 Completed - Cancer Clinical Trials

Pain Management in Cancer Patients Using a Mobile Application

ePAL
Start date: February 2014
Phase: N/A
Study type: Interventional

The investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. This study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that subjects randomized to the intervention group will have a reduction in pain and pain-related hospitalizations.

NCT ID: NCT02069470 Completed - Cancer Clinical Trials

The Effect of CME on Early Cancer Diagnosis in General Practice

Start date: September 2012
Phase: N/A
Study type: Interventional

Background Denmark has a lower survival of cancer compared to most European countries. Fast track pathways for organ specific cancers were established in the years 2008-2010. In 2011 further a fast track pathway for non-specific serious symptoms. Cancer in general practice is a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer patients per year. The investigators know that cancer patients have an increased use of general practice prior to diagnosis and that 25% of them wait for more than 20 days in general practice for referral according to the GPs. The latest Danish Cancer Plan therefore includes a CME as a key strategy to lower the GP threshold to refer patients to cancer fast track pathways. The aim of this study was to investigate the effect of this CME in early cancer diagnosis. This is measured by changes in GP knowledge, attitude and risk assessment. GP referral behavior assessed by primary care interval and use of fast track referrals. GP´s cancer hit rate, cancer patients´ tumor stage at treatment and 1 year survival. Methods/Design The study is conducted as a stepped wedge controlled design based on a quasi-cluster randomization. In august 2012 an invitation to participate in the present study were sent to 859 general Practitioners (GPs) from the Central Denmark Region. GPs completed a form for each patient they referred to a fast-track diagnostic pathway for cancer within an 8-month period. Every other week, we received data from a regional database. We reminded the referring GP-practice about non included patients. The collected data will be linked to registries. The CME-intervention The CME-course was a 3-hour meeting after work. Guided by the available evidence from the literature following the investigators ensured a multifaceted interactive teaching method including case-based education. The content included by other topics positive predictive values, false reassurance from negative testing and other pit-false. Statistical analyses The outcomes will be analyzed in a generalized linear random-effects model with random effect of GPs. Based on data it will be assessed whether further modeling of inter correlation within practices and within clusters is required, and whether the intervention effects are assumed equal for all GPs, or in random interaction with them. Analyses will be performed both in the full GP-population ("intention to intervening ") and in the 3 subgroups of GPs.

NCT ID: NCT02065063 Completed - Cancer Clinical Trials

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors

Start date: April 22, 2014
Phase: Phase 1
Study type: Interventional

This is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to determine the recommended dose and schedule for the orally administered MEK inhibitor trametinib, given together with the CDK4/6 inhibitor palbociclib in subjects with solid tumors. Multiple dose levels of each inhibitor will be tested to determine the recommended dose and schedule. Part 2 will evaluate the effect of the combination on tumor biomarkers safety, and anti-cancer activity in subjects with cutaneous melanoma that do not have a change at BRAFV600. Approximately 100-200 subjects will be enrolled. All subjects will receive trametinib and/or palbociclib until disease progression, death, consent withdrawal or unacceptable adverse event (AE). Data was only collected and analyzed for the Phase I component of the study, the Phase II component of the study was terminated without data collection

NCT ID: NCT02063958 Completed - Cancer Clinical Trials

Safety and Pharmacology of SNX-5422 Plus Everolimus in Subjects With Neuroendocrine Tumors

Start date: February 2014
Phase: Phase 1
Study type: Interventional

Study is designed to determine the maximum tolerated dose (MTD) of SNX-5422 when given in combination with everolimus.

NCT ID: NCT02060578 Completed - Cancer Clinical Trials

Determinants of End-of-life Place of Care for Children Suffering From Cancer.

DELI-DEVI
Start date: January 2014
Phase: N/A
Study type: Interventional

Cancer is the second cause of over-one-year-old children mortality after accident. Survival rate is more than 70%, but in some cases, curative treatments are not sufficient and palliative support is implemented for those children in end of life. Pediatric guidelines about the place of end-of-life care are varied. On European scale, home is recommended (IMPaCCT study, 2007). In France, the 2008-2012 palliative care development program recommended home or initial hospital care unit. This program also supports implementation of mobile team rather than specific hospital units. In Brittany, a pattern of regional palliative care resource team has been implemented since 2005. In oncology, further to the guidelines, end-of-life place of care is often discussed several times for each case. Sometimes occur a lot of returns between home and hospital, psychological difficulties, and difficulties to offer adapted care conditions. Finally, less than 30% of children in palliative care decease at home. The primary objective is to identify main determinants of the place of palliative care in pediatric oncology. The secondary objective is to clarify the factors of change comparing to the initial planned place. Intervention : Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2) Number of subjects is : Parents of 68 to 93 children who died from cancer after a palliative phase, that means 136 to 186 parents. Expected results and perspectives : Using both quantitative and qualitative methods, expected results are the followings: - Identification of the objective and subjective factors, which influenced the decision of the place of care. - Determination of the factors of change comparing to the initial planned place. Once identified, main factors could be the ones to pay attention to in order to help for initial decision, better anticipation of change of place and better guidance of palliative care organization wherever, at home or in hospital. Results would be new information for research on palliative care for children but also for adults. Finally, this work is part of an improving approach of palliative care, related to the development of open-care hospital networks. We can expect some public health impacts with new arguments to help for complementary recommendations.

NCT ID: NCT02055066 Completed - Cancer Clinical Trials

A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer.

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.

NCT ID: NCT02054754 Completed - Cancer Clinical Trials

Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

Start date: January 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.

NCT ID: NCT02048865 Completed - Cancer Clinical Trials

Apixaban for the Prevention of Venous Thromboembolism in Cancer Patients

AVERT
Start date: March 24, 2014
Phase: Phase 2
Study type: Interventional

Cancer patients have an increased risk of developing blood clots in the veins compared to non-cancer patients. Cancer patients who develop blood clots can lead to reduced life expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most effective way to decrease the complications associated with blood clots in the veins. Although previous clinical trials have shown some benefit on the use of medication to prevent blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive in demonstrating that existing blood thinners significantly reduce the rate of blood clots in cancer patients. One possible explanation relates to the fact that these studies have included a large proportion of cancer patients who are a low risk of developing blood clots in the veins. We are proposing to identify cancer patients who are at a high risk of developing blood clots by using a validated tool at the time of their cancer diagnosis. The identified high risk cancer patients will be asked to participate in a trial to test the safety and efficacy of a new oral medication that has been used to prevent blood clots in patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa, Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will receive the study drug and 287 will receive an inactive substance. Analysis will be performed to assess the safety and the superiority of the study drug.

NCT ID: NCT02040480 Completed - Cancer Clinical Trials

Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib

Start date: February 5, 2014
Phase: Phase 1
Study type: Interventional

This study is being conducted to measure the relative bioavailability of the original gelatin capsule formulation and a new formulation, immediate release (IR) tablet of Afuresertib (GSK2110183). The study will be composed of Screening, Treatment, and Follow-up Periods. A subject's total time involved in the study will be approximately 9 weeks. The study will enroll approximately 18 healthy volunteers.