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Advanced Cancer clinical trials

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NCT ID: NCT03323489 Completed - Pain Clinical Trials

Celiac Plexus Radio-Surgery for Pain Management

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Many cancer patients, especially those with pancreatic cancer, suffer from severe lower back / upper abdominal pain. This pain is often poorly managed with standard treatments; the doses of painkiller required often induce side effects, whereas nerve block procedures (where a needle is deeply inserted into the back) are both invasive and of limited benefit. This clinical trial investigates a unique novel approach in which high-dose radiation (radiosurgery) is focused on the offending nerve bundle (the celiac plexus) in the posterior abdomen. Preliminary results from a single institution pilot trial are very promising: pain relief is substantial and side effects minimal. In this multi-center clinical trial, patients will be accrued and receive treatment at several international locations. Main aim of the study: Establish the safety and efficacy of the treatment in the multi-center setting. This trial will bring pain relief to cancer sufferers and improve current acceptable standard of care. The trial resonates with the Gateway mission of promoting new treatments that directly benefit people living with cancer, enhancing their wellbeing, and consequently decreasing the fear associated with a cancer diagnosis.

NCT ID: NCT03316157 Completed - Physical Activity Clinical Trials

Exercise and Nutritional Rehabilitation in Patients With Cancer

ENeRgy
Start date: January 30, 2018
Phase: N/A
Study type: Interventional

In patients with incurable cancer, general deterioration in their ability to walk, exercise and care for themselves is often regarded as an inevitable consequence of this. In 2015, Hospice UK published a report advocating "Rehabilitative Palliative Care". However there is limited robust evidence on which to base this approach. Reviews of the literature show limited study numbers but do suggest that rehabilitation may be feasible for advanced cancer patients. However key components were not clear and no recommendations could be given. This trial is designed primarily to test the feasibility of a rehabilitation programme (exercise and nutritional supplementation) in advanced cancer patients. Feasibility will be the primary outcome measure including rates of recruitment and compliance. Secondary outcome measures include impact on physical function, nutritional status, quality of life for patients and their carers. We will also assess the health economic impact by assessing patient health facility use throughout the trial. 40 patients with advanced cancer living in the community will be recruited from two hospice palliative care teams in Edinburgh. These patients will be randomised in to either the treatment arm: the rehabilitation programme plus standard care, or the control arm: standard care alone. The treatment arm will consist of an 8 week rehabilitation programme, supervised at weekly clinics by a physiotherapist and dietician. To minimise contamination the control group will be offered the treatment at the end of the 8 weeks (waiting list control). Measurements will be made for both groups and compared at baseline (week 0), midpoint (week 5) and endpoint (week 9). Recommendations for a larger UK wide trial will be made from the findings of this study.

NCT ID: NCT03312842 Completed - Advanced Cancer Clinical Trials

A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

Start date: October 19, 2017
Phase: Phase 1
Study type: Interventional

This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.

NCT ID: NCT03307785 Active, not recruiting - Neoplasms Clinical Trials

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

Start date: October 12, 2017
Phase: Phase 1
Study type: Interventional

Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part B: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part C: To test the safety and tolerability of combination therapy with Niraparib, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study. Part D: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study. Part E: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part F: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part G: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part H: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part I: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.

NCT ID: NCT03285633 Completed - Advanced Cancer Clinical Trials

Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

This study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment.

NCT ID: NCT03261011 Recruiting - Advanced Cancer Clinical Trials

Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK104 in Subjects With Advanced Solid Tumors

Start date: October 3, 2017
Phase: Phase 1
Study type: Interventional

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK104 as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK104 as a single agent, and a dose expansion phase (Phase 1b) which will characterize treatment of AK104 as a single agent at the MTD or RP2D.

NCT ID: NCT03260712 Completed - Metastatic Cancer Clinical Trials

Pembrolizumab in Biliary Tract Cancer

Start date: January 7, 2020
Phase: Phase 2
Study type: Interventional

This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab.

NCT ID: NCT03258541 Terminated - Rectal Cancer Clinical Trials

Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy

Start date: January 15, 2017
Phase: N/A
Study type: Interventional

For advanced rectal tumors, the standard of care is neoadjuvant radiotherapy (RT) +/- chemotherapy followed by surgery 8-10 weeks later. Despite its proven efficacy in reducing local relapse, the neo-adjuvant treatment has been associated to non-negligible side effects, especially in terms of impaired sexual function. For females, pelvic RT is frequently associated to long-term complications such as vaginal stenosis (VS), vaginal dryness, and dyspareunia, while in men RT doses delivered to the neurovascular peri-prostatic bundles and penile bulb have been associated to the risk to develop erectile dysfunction. In prostate cancer, hydrogel spacers have been evaluated to create space between the target (prostate) and the organ (rectum) to be spared during radiotherapy treatments. Clinical studies have shown the ease of spacer application; patient tolerance and, good clinical outcomes (decrease in rectal toxicities). This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.

NCT ID: NCT03254173 Completed - Advanced Cancer Clinical Trials

Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia

MCACS100
Start date: March 26, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

A randomized controlled clinical trial will be conducted to assess the efficacy of the FDA approved drug , mirtazapine , in treatment of cancer associated anorexia cachexia syndrome. Two arms will be compared . Arm A will involve 50 patients with confirmed advanced cancer receiving mirtazapine 15 mg once daily for 8 weeks & Arm B will involve another 50 patients with confirmed advanced cancer receiving placebo for 8 weeks. Both arms will be compared to assess efficacy of mirtazapine in appetite stimulation primarily and to assess other outcomes secondarily which will be discussed later in details.

NCT ID: NCT03252678 Completed - Advanced Cancer Clinical Trials

Efficacy of Self-education Program for Advanced Care Planning(RCT)

Start date: August 17, 2017
Phase: N/A
Study type: Interventional

This study verifies efficacy of Self-education program for advanced care planning. Half of participants will receive a book and videos about advanced care planning while the other half will receive a book and videos about pain control for cancer patients.