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Neoplasm Metastasis clinical trials

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NCT ID: NCT04369872 Recruiting - Neoplasm Metastasis Clinical Trials

Microwave Ablation of Primary and Secondary Lung Malignancies

Start date: May 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Surgery is the first choice of treatment for early-stage primary pulmonary malignancies, but up to 15% of all patients, and 33% of patients greater than 75 years of age, are not surgical candidate's due to locally advanced disease, poor cardiopulmonary reserve and significant medical co-morbidities. Some patients are also unwilling to undergo surgery. This has prompted the development of alternatives to surgery so that local control of unresectable tumors can be achieved. Stereotactic body radiation therapy (SBRT) is currently an alternative therapy for these patients with 3-year survival rates of between 42 and 60%. SBRT has excellent local control rates and a favorable toxicity profile relative to other surgical and non-surgical therapies. Radiation pneumonitis (RP), amongst others, is one of the major toxicities which can limit the maximal radiation dose that can be safely delivered to thoracic tumors. Reported rates of SBRT induced RP requiring clinical intervention range from 0% to 29% and life-threatening toxicities have been reported in up to 12% of cases in various studies. The potential for toxicities from SBRT could limit the number of times a patient could be treated with SBRT for residual, recurrent or new pulmonary lesions over time. Following the first report of thermal ablation for lung malignancies in 2000, this modality has been used to treat primary and secondary malignancies and has emerged as an effective, low-cost, safe and repeatable alternative to SBRT for local tumour control. The most widely practised technique is radiofrequency ablation (RFA). Microwave ablation (MWA) is a relatively new therapy and offers all the advantages of RFA, but with significant additional advantages 3. These include reduced procedure times, lower complication rates, increased ablative temperatures, improved propagation of thermal energy particularly in the lung, improved efficacy in lesions that are in close proximity to blood vessels due to reduced heat-sink effect, and less procedure associated pain 2,3. Using high energy MWA to treat 87 pulmonary tumors, Egashira et al achieved a primary technical success rate of 94% and technique effectiveness of 98% at a median of 15 months. MWA is performed by Interventional Radiologists using CT guidance. The treatment is performed under general anaesthesia and is repeatable. Multiple lesions can be ablated in one treatment session. Patients can potentially be discharged the same day of treatment, if there are no adverse events. MWA is a relatively new treatment option that could be considered in situations where the patient is not a candidate for further treatment with surgery, SBRT or chemotherapy, or the patient declines the recommended standard available treatments. Objectives for Phase I: The primary objective for Phase I of this study will be to demonstrate the Safety of MWA performed for treatment of lung malignancy in patients not suitable for surgery, chemotherapy or SBRT. Primary objective (Safety): to determine the proportion of patients experiencing local adverse events at one week definitively related to the mwa procedure. Secondary objective (Feasibility): To determine the proportion of patients in whom technical success of MWA was achieved by assessing completion of ablation on CT at the time of the procedure, indicated by replacement of tumor by ground glass change (including a 5mm ablation zone in normal surrounding lung parenchyma). Objectives for Phase II Primary objective (Efficacy): To demonstrate efficacy by measuring the proportion of patients demonstrating absence of residual tumor on follow up CT at 1 month after MWA. Secondary objective: To determine the proportion of patients needing re-treatment for recurrent tumor at 1 month post MWA.

NCT ID: NCT04365374 Recruiting - Brain Metastases Clinical Trials

Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)

Start date: April 6, 2021
Phase: Phase 3
Study type: Interventional

This trial will be a randomized controlled study comparing the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current standard of care.

NCT ID: NCT04358666 Recruiting - Quality of Life Clinical Trials

Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis

OPTMETACER
Start date: March 6, 2020
Phase: N/A
Study type: Interventional

Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion. second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol

NCT ID: NCT04356222 Not yet recruiting - Clinical trials for Leptomeningeal Metastasis

Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Start date: June 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis

NCT ID: NCT04356118 Not yet recruiting - Clinical trials for Leptomeningeal Metastasis

Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Start date: June 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis

NCT ID: NCT04354129 Recruiting - Clinical trials for Primary Immune Deficiency Disorder

Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.

Start date: April 1, 2023
Phase:
Study type: Observational

This study will assess the relative safety, tolerability, and participant satisfaction in participants using the rapid manual push method with Cutaquig®. The hypothesis being that treatment with Cutaquig® by rapid manual push method will improve the safety, tolerability and patient satisfaction of participants with PID or SID. Cutaquig® by rapid push is already approved in Canada and has proven to be efficacious in preventing significant infection. However, relative safety, tolerability, and patient satisfaction have not been studied in these patients. The information gained from this study will improve the safety and tolerability knowledge database and will support the optimal use of Cutaquig® - thus benefitting both physicians and patients.

NCT ID: NCT04348916 Terminated - Breast Cancer Clinical Trials

Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors

Start date: May 20, 2020
Phase: Phase 1
Study type: Interventional

ONCR-177-101 is a phase 1, open-label, multi-center, dose escalation and expansion study of ONCR-177, an oncolytic Herpes Simplex Virus for intratumoral injection, alone and in combination with PD-1 blockade in adult subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with Liver Metastases of Solid Tumors. The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

NCT ID: NCT04345146 Completed - Clinical trials for Non-small Cell Lung Cancer

Bevacizumab Combined With Fractionated Stereotactic Radiotherapy for 1 to 10 Brain Metastases From NSCLC

Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

This Phase II randomized study is to determine the efficacy and safety of Bevacizumab combined with fractionated stereotactic radiation therapy(FSRT) in patients with 1 to 10 brain metastases in non-small cell lung cancer by assessing the treatment response, perilesional edema, neurological symptoms and quality of life.

NCT ID: NCT04343573 Active, not recruiting - Clinical trials for Leptomeningeal Metastases

Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors

Start date: April 10, 2020
Phase: Phase 2
Study type: Interventional

The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy. Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.

NCT ID: NCT04343456 Completed - Metastasis Clinical Trials

Salvage Surgery for Patients With Metastatic GIST With Rego

Start date: January 1, 2014
Phase:
Study type: Observational

Some researches have shown surgery may acquire progression-free (PFS) benefit for selected patients with metastatic gastrointestinal stromal tumor (GIST) who received first-line imatinib and second-line sunitinib. However, impact of salvage surgery on pre-treated GIST patients receiving third-line regorafenib facing progression is not yet reported. Investigators retrospectively reviewed patients with regorafenib treatment with salvage surgery.