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Bone Neoplasms clinical trials

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NCT ID: NCT03887494 Not yet recruiting - Hip Fractures Clinical Trials

Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)

WAZA-ARY
Start date: September 6, 2019
Phase: N/A
Study type: Interventional

Bone metastases appear in many cancers. They are associated with severe pain that is refractory to standard treatment. Improving the quality of life and better pain relief is therefore an essential goal of the treatment of metastatic disease. The most common site of long bone metastases is the superior femoral epiphysis. The usual management of patients with bone metastases in the superior femoral epiphysis is based on gamma implant osteosynthesis when there is a known risk of fracture (Mirels score> 8). Nonetheless this surgery is only accessible to a few patients because of the associated morbidities. Percutaneous cementoplasty has been developed to treat patients who are not eligible for conventional surgery. It consists in a filling of the bone cavity created by metastasis using an acrylic resin. However, these approaches do not completely prevent the risk of upper femoral epiphyseal fracture due to the low mechanical resistance of the resin to shear movements. The Y-STRUT® implantable medical device was developed to overcome this risk of superior femoral epiphyseal fracture by the biomechanical strengthening of the proximal femur in addition to cementoplasty. It has been successfully tested in more than 70 patients with cancer but access to reimbursement and the APHP market have been postponed due to lack of sufficient clinical evidence. The investigators propose this prospective phase 2a study in order to provide evidence of the performance of the Y-STRUT® implant.

NCT ID: NCT03869762 Terminated - Metastatic Cancer Clinical Trials

Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases.

DICE
Start date: January 9, 2019
Phase: Phase 2
Study type: Interventional

Open-label phase II multi-centre single arm study of Denosumab in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.

NCT ID: NCT03839095 Completed - Bone Neoplasms Clinical Trials

Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model

Start date: January 1, 2018
Phase:
Study type: Observational

To assess survival outcome of pediatric patients with localized osteosarcoma of the extremities in Upper Egypt, identify factors of prognostic significance for survival, and to determine factors predictive of surgical methods employed in these patients, and developing a clinical model for risk prediction.

NCT ID: NCT03814811 Recruiting - Breast Neoplasms Clinical Trials

Circulating Osteocalcin-positive Cells in Breast Cancer Bone Metastasis

COP-BREAST
Start date: July 1, 2017
Phase:
Study type: Observational

Bone metastasis (i.e. cancer cell spreading to bone) is the major clinical problem of advanced breast cancer patients. Bone metastasis is not curable nor preventable. Currently available therapeutic approaches are only palliative. The major hurdle for improving bone metastasis treatment is lack of sensitive diagnostic tools. Diagnosis of bone metastasis is heavily dependent on radiographic imaging of bone destruction that are detectable only when the lesion is significantly large. Accordingly, if bone metastasis can be detected at an earlier time point when bone destruction is minimal or incipient, treatments can be given earlier and the patients can expect better outcomes. We and others previously have found that a subset of bone-forming cells (i.e. circulating osteocalcin-positive cells) exists in the blood stream of the patients with bone diseases (e.g. bone metastasis and inflammation) or active bone formation (e.g. adolescence) in mouse models anf human samples. Extended from this laboratory observation, this clinical study proposes to test the hypothesis that circulating osteocalcin-positive cells are the early biomarker of breast cancer bone metastasis. For this aim, this study will measure circulating osteocalcin-positive cells in the blood samples of breast cancer patient, and examine whether the measure sensitively detects bone metastasis.

NCT ID: NCT03780036 Not yet recruiting - Clinical trials for Bone Neoplasm of Hip (Diagnosis)

Megaprosthetic Implants the Next Generation (MING)

MING
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

This is an interventional randomized controlled trial that will compare patients who underwent segmental hip replacement using mega-implants with either porous collar or porous collar with HA. Patient recruitment will continue for 18 months. Parameters to be investigated are radiographic measures of bone incorporation into the implants, as well as patient functional outcomes. Clinical follow-up will last for 24 months for each patient.

NCT ID: NCT03678883 Active, not recruiting - Cancer Clinical Trials

9-ING-41 in Patients With Advanced Cancers

Start date: January 4, 2019
Phase: Phase 2
Study type: Interventional

GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

NCT ID: NCT03669523 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Denosumab and Nivolumab Combination as 2d-line Therapy in Stage IV NSC Lung Cancer With Bone Metastases (DENIVOS)

DENIVOS
Start date: November 6, 2018
Phase: Phase 2
Study type: Interventional

Bone metastases are common in Non-Small Cell Lung Cancer (NSCLC). They most often occur during disease progression. It is thought that more than half of the patients with bone metastases will have at least 1 skeletal-related event (SRE, i.e. pathological fractures, medullary compression, analgesic radiotherapy, preventive and/or analgesic surgery and hypercalcemia). Expert and medical Society guidelines, notably European Society for Medical Oncology in 2014, then in 2016, recommended using anti-resorptive agents (bisphosphonates or denosumab) to prevent SREs, attenuate pain and improve the quality of life, and decrease the medical-economic impact of this major metastatic site. Denosumab was accorded marketing authorization in France in 2011 as an anti-resorptive agent for bone metastases to delay the occurrence of SREs in lung-cancer patients. Immunotherapy, notably immune-checkpoint inhibitors, like nivolumab (anti-programed death-1), has recently become an integral part of the therapeutic arsenal against NSCLCs. Nivolumab was accorded marketing authorization based on the phase III CHECKMATE 017 (squamous cell NSCLCs) and CHECKMATE 057 (non-squamous cell NSCLCs) trials versus docetaxel, after the phase II CHECKMATE 063 trial. The denosumab-nivolumab combination is commonly used in current practice but has not been evaluated prospectively. The aim of this trial is to evaluate the combination of denosumab and nivolumab in second line of NSCLC with bone metastases.

NCT ID: NCT03661892 Completed - Breast Cancer Clinical Trials

Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets

Start date: December 19, 2018
Phase: Early Phase 1
Study type: Interventional

In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.

NCT ID: NCT03605199 Recruiting - Chondroblastoma Clinical Trials

Denosumab in Subjects With Giant Cell Rich Tumors of Bone

Start date: June 18, 2018
Phase: Phase 2
Study type: Interventional

An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant).

NCT ID: NCT03597984 Not yet recruiting - Radiotherapy Clinical Trials

Reduction of Pain Symptoms With Stereotactic Radiotherapy on Bone Metastases

PREST
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Interventional study without medicinal, randomized 1: 1 open-label, multicenter, phase 3 to evaluate the response in terms of reduction of pain symptomatology from bone metastases, comparing the conformational radiotherapy (3D-CRT) administered in conventional fractionation vs. extracranial stereotactic radiotherapy (SBRT) administered with concomitant integrated simultaneous boost (Simultaneous Integrated Boost-SIB)