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Neoplasm Metastasis clinical trials

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NCT ID: NCT02714010 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC

Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.

NCT ID: NCT02711007 Completed - Osteosarcoma Clinical Trials

Apatinib for Advanced Osteosarcoma After Failure of Standard Multimodal Therapy

Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades.Thus, the investigators explored apatinib activity in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy. Patients >16 years, progressing after standard treatment, were eligible to receive 500 mg or 750 mg of apatinib once daily until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) at 4 months and objective response rate (ORR). Secondary objectives were PFS, overall survival (OS), clinical benefit rate (CBR), defined as no progression at 6 months and safety.

NCT ID: NCT02707510 Completed - Breast Neoplasms Clinical Trials

A Trial to Strengthen Existential Resiliency Among Women With Metastatic Breast Cancer

Start date: October 2016
Phase: N/A
Study type: Interventional

The investigators group has piloted a 6-week psycho-educational program, Growing Resiliency And CouragE with Cancerâ„¢ (GRACE), that bring together a variety of strategies and experiences from an inter-professional perspective to mitigate distress among patients with an advanced cancer diagnosis. GRACE is a six-session, empirically anchored intervention emphasizing a Logotherapy (Existential Therapy) and Cognitive-Behavioral Therapy approach involving psycho-education and process-oriented experiences. The curriculum includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.

NCT ID: NCT02706964 Completed - Breast Cancer Clinical Trials

Imaging the Patterns of Breast Cancer Early Metastases

BCMetPats
Start date: April 2016
Phase: N/A
Study type: Interventional

Currently, once a distant breast metastasis has been diagnosed, 65% of patients will succumb to their cancer within 2 years, and 80% will succumb by 5 years. The current National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer do not recommend surveillance imaging for earlier detection of distant metastases, even for high-risk breast cancer patients. Whereas, the standard-of-care treatment of the small isolated (few in number) breast cancer metastases is to perform surgical resection or locally ablative radiation therapy, however, the follow-up of breast cancer patients (including those with a >= 30% risk of developing metastases) is to wait for clinical symptoms to appear before using a dual positron emission tomography (PET) and diagnostic quality computed tomography (CT) PET/CT scan, magnetic resonance imaging (MRI), computed tomography (CT) or a bone scan to identify the site and extent of spread. Unfortunately, once metastases become symptomatic they are often too large and/or numerous to treat with curative intent. The current national care guidelines that advocate against intensive surveillance for distant metastases are based on two studies performed in Italy from 1985-1993 that concluded that the available imaging and treatment tools of the day did not prolong 5-year survival. Since then, however, there have been major improvements in imaging and treatment technology. To be treatable the metastases must be limited in number and limited in size, typically 6 or fewer metastases, each of size 5 centimeter or less. This state of metastatic presentation is called oligometastases. Numerous pilot studies have achieved dramatically improved overall and disease-free survival when oligometastases are treated using a combined systemic plus locally-ablative therapy of each oligometastasis. A scientific concern with the aforementioned research studies involving ablation of isolated oligometastases, was that they were not carried out with consistent use of surveillance imaging. Instead, these studies effectively preselected patients for enrollment based upon having an existing oligometastatic presentation. The primary objectives of the research study are to: (1) determine the feasibility of the stated interventions in a multi-institutional setting; (2) document the patterns of early metastatic spread of breast cancer; (3) document the proportion of high-risk breast cancer patients that have an oligometastatic presentation within this proactive imaging protocol, and (4) provide a basis to determine how to optimize future surveillance imaging protocols with respect to the time to progression, rate of tumor growth and organs that are affected.

NCT ID: NCT02705183 Recruiting - Metastasis to Bone Clinical Trials

Post-operative RadioTherapy for Patients With Metastases of the Long Bones

PORT
Start date: January 2016
Phase: N/A
Study type: Interventional

Rationale: Bone metastases arise in 50% of all patients dying of cancer, increasing up to 70% in patients with breast and prostate cancer. The lesions can cause pain and fractures, leading to diminished quality of life and poorer survival. Current knowledge concerning adequate, personalized treatment of metastatic lesions of the long bones in patients with disseminated cancer is insufficient and inconclusive due to lack of large, prospective series with patient reported outcome measures. One of the debatable issues is the effectiveness of postoperative radiotherapy. It has become common practise due to professional opinion, but research evidence is lacking. It is thought that adjuvant radiotherapy improves the durability of an implant, prevents progression of the lesion, promotes bone healing, improves limb function, minimises pain and reduces the need for reoperations, however none of these are certain. Moreover, it is a burden on patient's quality of life (e.g. multiple extra hospital visits) causing toxicity and possible side effects (e.g. skin irritation). The true beneficial effect, weighing up the possible pros and certain cons, of adjuvant radiotherapy is thus unknown. Objective: The PORT study aims to demonstrate the non-inferiority of 'surgery only' compared to surgery with adjuvant radiotherapy as treatment of impending and actual pathological fractures on the pain experienced by patients. Study design: A multicentre, prospective, randomised non-inferiority trial nested within the OPTIMAL study. Study population: All patients with metastases of the long bones undergoing surgery for a(n) (impending) pathologic fracture in the participating centres. Study intervention: One study arm (A) will receive surgery with adjuvant radiotherapy; the other study arm (B) will receive surgery only. Main study parameters/endpoints: Primary endpoint is patient reported pain according to a numeric rating scale (NRS). Clinical functioning, radiological status, complications and survival are secondary endpoints.

NCT ID: NCT02705157 Recruiting - Bone Metastasis Clinical Trials

The OPTIMAL Study - A Prospective Cohort of Patients With Bone Metastases of the Long Bones

OPTIMAL
Start date: January 2016
Phase: N/A
Study type: Observational [Patient Registry]

Rationale: Bone metastases arise in 50% of all patients dying from carcinoma, increasing up to 70% in patients with breast and prostate cancer. The lesions can cause pain and fractures, leading to diminished quality of life and poorer survival. Current knowledge concerning adequate, personalized treatment of metastatic lesions of the long bones in patients with disseminated cancer is insufficient and inconclusive due to lack of large, prospective series with patient reported outcome measures. Objective: The OPTIMAL cohort aims to describe the quality of life and pain perception of patients after local treatment (radiotherapy and/or surgery) of metastases of the long bones, for both the entire cohort as well as for specific treatments separately. With this a more personalized treatment for metastases in the long bones based on expected survival and impending fracture risk can be provided in order to improve functioning and the quality of life for the remaining lifetime in patients with disseminated cancer. Study design: Observational, prospective, multicentre cohort study. Study population: All patients with metastases of the long bones visiting a radiation oncologist or orthopaedic surgeon. Main study parameters/endpoints: Primary endpoints are patient reported quality of life (including functioning) and pain levels. Complications and survival are secondary endpoints. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the OPTIMAL cohort will perhaps not directly benefit from their participation. Participation will contribute to deriving patient-specific treatment modalities for future patients with bone metastases of the long bones. Risks associated with participation in the prospective cohort are considered negligible due to the observational nature of the study. The burden for the patients lies in completion of questionnaires, which is considered to be in proportion with the potential value of this research.

NCT ID: NCT02702323 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other half will receive TACE therapy alone.

NCT ID: NCT02701907 Completed - Metastatic Cancers Clinical Trials

EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies

EXPRESS
Start date: December 2016
Phase: N/A
Study type: Interventional

Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having presented an exceptional and unexpected response to an antineoplastic targeted therapy.

NCT ID: NCT02700763 Terminated - Melanoma Clinical Trials

[18F]Dabrafenib Molecular Imaging in Melanoma Brain Metastasis

Start date: December 6, 2016
Phase: N/A
Study type: Interventional

In this feasibility study, [18F]dabrafenib will be used as radioactive tracer. All patients in this study are diagnosed with advanced melanoma with evidence of brain metastases and are eligible for treatment with dabrafenib, a specific V600-mutated BRAF inhibitor. Patients will undergo a dynamic PET scan of the brain to determine [18F]dabrafenib distribution and kinetics in brain metastases. In addition, a static total body PET scan will be performed to visualize whole body distribution and tracer uptake.

NCT ID: NCT02700308 Terminated - Solid Tumors Clinical Trials

A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases

KYPHO-01
Start date: March 2016
Phase: Phase 2
Study type: Interventional

Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture. The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments. Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space. In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage. To date, no data from randomized study are available in the population of cancer patients.