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Neoplasms, Second Primary clinical trials

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NCT ID: NCT03507244 Completed - Clinical trials for Leptomeningeal Metastasis

Concurrent Intrathecal-pemetrexed and Involved-field Radiotherapy for Leptomeningeal Metastasis From Solid Tumors

Start date: April 12, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Intrathecal chemotherapy is one of the most important treatment modalities for leptomeningeal metastasis of solid tumors. In the previous retrospective study, it has been proved that concurrent radiotherapy and intrathecal methotrexate for leptomeningeal metastasis from solid tumors with adverse prognostic factors showed great effectiveness and safety. The preliminary results of investigators' current prospective clinical study (Involved-field Radiotherapy Combined With Concurrent Intrathecal-methotrexate Versus Intrathecal-Ara-C for Leptomeningeal Metastases From Solid Tumor: A Randomized Phase II Clinical Trial. ClinicalTrials.gov identification number: NCT03082144) also showed that the regimen of concurrent intrathecal chemotherapy and radiotherapy may serve as an optimal therapeutic option for treatment of leptomeningeal metastases from solid tumors. Pemetrexed is a newer multitargeted antifolate which has shown activity in various tumors. In investigators' current study (Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A Prospective Pilot Clinical Trial. ClinicalTrials.gov identification number: NCT03101579), the regimen of intrathecal pemetrexed with folic acid and vitamin B12 supplementation may provide higher effectiveness and safety for recurrent leptomeningeal metastasis from non-small cell lung cancer. Therefore, the purpose of the study is to evaluate the tolerability, safety and effectiveness of intrathecal pemetrexed combined with involved-field radiotherapy as the first line treatment in patients with leptomeningeal metastases from malignant solid tumors.

NCT ID: NCT03453892 Completed - Metastatic Cancer Clinical Trials

Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition

ST-ICI
Start date: April 1, 2017
Phase:
Study type: Observational

Immunotherapy for the treatment of several cancer entities steadily increased during the last years. The data from the finalized and ongoing studies show the tremendous impact of immune checkpoint inhibition (ICI) also for advanced metastatic patients. Especially the ICI with pembrolizumab and nivolumab have an increasing number of first line treatment approvals. However, in particular metastatic patients which receive ICI therapy are often irradiated for immediate palliation of several metastases. Preclinical work revealed that radiotherapy (RT) is capable to modulate the tumor phenotype, its microenvironment in a way that systemic anti-tumor immune responses are induced. However, radiation has also immune suppressive properties as e.g. the expression of immune checkpoint molecules is increased following radiotherapy. So the ICI therapy in combination with the RT has the potential to overcome the immunotolerance of the tumor and the metastases. More and more reports therefore describe a so-called systemic immune-modulating effect of radiotherapy (former and still often named as abscopal effect). However the timely application of ICI and RT is often randomly and depends on the clinical need for the palliative RT. The aim of this trial is therefore to standardize the chronology of RT in combination with ICI, to evaluate the effects of radio-immunotherapy with a stratified and comparable patient cohort. The ST-ICI study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the radio-immune therapy drives systemic anti tumor responses.

NCT ID: NCT03336905 Completed - Neoplasms Clinical Trials

Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs

PREVAPAJA
Start date: November 9, 2016
Phase: N/A
Study type: Interventional

About 700 new cases of cancer are recorded each year among TYAC aged 15 to 25 years old in Rhône-Alpes region (France); more than 200 are treated and supported within the TYAC Department of the Institute of Hematology and Oncology Pediatrics (Centre Léon Bérard-Civil Hospice of Lyon). These patients survive from their disease in 80% of cases; they have six times more likely to develop a risk of second primary cancer (SCP) than their peers. This risk of SCP is multifactorial and varies depending on the type of first cancer, treatment received and the prevalence of risk factors (smoking, overweight, sedentary lifestyle, environmental exposures...). This project aims to implement a clinical program based on adapted physical activity (APA) and cancer prevention recommendations for TYAC during the active treatment period (4-6 months). The methodology used series of assessments of APA sessions and information meetings dedicated to cancer prevention and SCP risk recommendations. It mobilizes regularly the health care team of TYAC Department, TYAC associations, sports structures and associations involved in cancer prevention at the regional level. Assessment of TYAC satisfaction regarding the project, benefits in terms of exercise practice, and knowledge improvement on cancer prevention recommendations, are assessed throughout the program.

NCT ID: NCT03318068 Completed - Quality of Life Clinical Trials

Outpatient Yoga Study for Adolescents Receiving Chemotherapy

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

LAY SUMMARY: The diagnosis and treatment of pediatric cancer is a significant stressor for adolescents and their families . Although most adolescents cope well with their cancer diagnosis, many experience emotional distress. A small proportion of those diagnosed with cancer will experience more intense mental distress, such as depression, anxiety, or anger. The practice of yoga may be a possible way of treating the negative emotional symptoms experienced by these adolescents. Previous studies suggest that yoga may improve anxiety, mood and psychological distress in adults with cancer. The results of two recent pediatric pilot studies show that yoga programs improved quality of life for adolescents receiving cancer treatment. Given this, we wish to examine the feasibility of offering a 10-week yoga program for adolescents who are receiving outpatient chemotherapy. This program includes both one-on-one in-person sessions and home-based sessions offered using SkypeTM. To assess this program, we will monitor patients' attendance, ask their opinions of the program and evaluate whether yoga improved their mental well-being. This study represents an important step toward identifying possible treatments to improve patients' quality of life and emotional health.

NCT ID: NCT03313193 Completed - Clinical trials for Treatment-Related Cancer

Acupressure for Children in Treatment for a Childhood Cancer

ACT-CC
Start date: September 26, 2017
Phase: N/A
Study type: Interventional

Background: Despite advances in symptom management, children undergoing cancer treatment or receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological distress. Pharmacologic treatments of symptoms can cause side-effects. Patients, parents, and clinicians have expressed interest in including non-pharmacologic approaches to improve symptom management. Acupuncture/acupressure is a promising adjunctive therapy to usual care. More evidence is needed from well-designed trials with larger samples and rigorous designs in order to make definitive recommendations about the routine inclusion of acupressure among pediatric patients being treated for childhood cancer or receiving a HSCT. Design and Methods 100 dyads (one child with one parent/caregiver) will be randomized 1:1 into 2 study arms (50 children in each arm). Arm A participants will be offered usual care and professional acupressure five times weekly (15-20 minute sessions) and a parent/caregiver will be instructed in acupressure delivery for the child as symptoms arise. Arm B participants will receive usual care alone. (At the study end, Arm B parents will be offered acupressure instructions.) Children will be enrolled for ~30 days which can occur with one month of continuous hospital-based treatment or two months of intermittent hospital-based treatment (inpatient or regular outpatient treatment). Parent and child participants will receive a follow-up interview one month after completion of the intervention (Arm A) or the final symptom assessment (Arm B). Significance This is the first study to evaluate the effectiveness and safety of an acupressure intervention to decrease treatment-related symptoms in 100 patients in treatment for a childhood cancer or receiving a chemo-therapy based HSCT.

NCT ID: NCT03293966 Completed - Clinical trials for Treatment Related Cancer

A Coordination Card of Care Relative to the Medicinal Treatments Got Out of it From Hospitalization

Start date: June 1, 2016
Phase:
Study type: Observational [Patient Registry]

The continuity of the medicinal care between the city and the hospital stays a major organizational stake and of safety of patients' therapeutic care.This takeover is more complex when it concerns pathology needed lots of hospitalization and included the intervention of multiple healthcare practionners. This is clearly the case of cancer coverage. The optimization of the therapeutic suppor in town is based on pharmaceutical advice strengthening but also on the pharmaceutical analysis to check the entire treatments' prescription and eventual medicinal interactions which ensue from it.That's why it's important to have a medicinal conciliation that takes into account all the medecine taken or have to be taken by the patient. A specific support was developped by nurses , doctors and pharmacist ; it's a care coordination card that can be put easely in a pocket by the patient. The aim of the study is that this card can be also used as a communication tools by sharing the prescription done at the release of hospital by using an IT link (flea datamatrix) for the patients Via the use of an IT link (flea datamatrix) for the patients whose pathology is complex in term of extra hospital coverage.

NCT ID: NCT03264716 Completed - Clinical trials for Unresectable Colorectal Liver Metastasis

Transarterial Chemoembolization by Hepasphere Microspheres for the Treatment of Unresectable Colorectal Liver Metastasis

Start date: August 31, 2017
Phase: N/A
Study type: Interventional

Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year approximately 60% will develop liver metastasis during the course of their disease. In approximately 30% of these patients who develop liver metastasis the metastatic disease will remain confined to the liver. For the 70-75% of colorectal patients with colorectal liver metastasis not suitable for hepatic resection or similarly ablative therapy with curative intent, systemic chemotherapy is the standard initial management. However, after a patient has failed first- line and in some cases second-line chemotherapy, response rates fall to as low as 12% (Chen HX 2006). Transarterial chemoembolization (TACE) with microsphere is an alternative treatment because normal liver tissue receives most of its blood supply from the portal vein, while colorectal liver metastases derive most of their flow from the hepatic artery. Several clinical trials have explored the feasibility and the efficacy of TACE with microsphere as a treatment for patients with colorectal liver metastasis. HepaSphere represents a novel drug delivery system for chemoembolization, which can add two benefits to embolization therapy. First, by ionically binding the doxorubicin throughout the microspheres, more drug can be delivered into the tumor, with less escape into peripheral circulation. Second, conformability to the architecture of the vessel lumen, providing more contact surface area with the embolic material and the vessel intima, leading to a more complete occlusion. However, there are limited experiences in using HepaSphere TACE for colorectal liver metastasis in Taiwan. In this pilot study, we will evaluate the initiate safety and efficacy of Hepasphere microspheres loaded with a chemotherapeutic agent doxorubicin for the treatment of patients who have failed first-line and second-line systemic chemotherapy.

NCT ID: NCT03101579 Completed - Clinical trials for Leptomeningeal Metastases

Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer

Start date: March 1, 2017
Phase: Phase 1
Study type: Interventional

It has been proved that intrathecal chemotherapy is the main treatment strategy for leptomeningeal metastases. At present, the commonly used drugs for intrathecal chemotherapy include methotrexate, cytarabine, and liposomal cytarabine. In recent decades, no new effective drugs have been discovered for intrathecal chemotherapy. The recurrence of leptomeningeal metastases is inevitable even after aggressive treatment. There is no effective treatment for recurrent leptomeningeal metastases after comprehensive treatment which includes intrathecal methotrexate and/or cytarabine, central nervous system radiation therapy, systemic chemotherapy as well as tyrosine-kinase inhibitor drugs. The quality of life is extremely poor, and the patients always die in short time. Pemetrexed is a newer multitargeted antifolate which has shown activity in various tumors. It has higher effectiveness and safety, which has been used as the first-line treatment of non-small cell lung cancer. In animal studies, pemetrexed was demonstrated to suppress tumor growth completely in mice with two types of transplanted human colon xenografts resistant to methotrexate. Therefore, the purpose of the study is to evaluate the safety and feasibility of intrathecal pemetrexed in patients with recurrent leptomeningeal metastases from non-small cell lung cancer.

NCT ID: NCT03101358 Completed - Clinical trials for Cutaneous Metastasis

Study of Topical SOR007 Ointment for Cutaneous Metastases

Start date: January 31, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates a topical nanoparticle paclitaxel ointment (SOR007) for the treatment of cutaneous metastases from non-melanoma cancer in adults. Three concentrations of SOR007 will be evaluated in dose-rising cohorts of three. An expanded cohort will treat additional subjects at the maximum tolerated dose.

NCT ID: NCT03031444 Completed - Metastasis Clinical Trials

Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis

PARECEC
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Scoreā‰„3) of resectable colorectal liver metastasis. The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.