Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

The objective is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma. In all cases, the decision to treat the patient with nab-paclitaxel in combination with gemcitabine was already made prior to the decision to enter the subject into the study. Treatment will be according to routine clinical practice and based on recommendations as per Summary of Product Characteristics (SPC).

Jeroen Stevens, Msc

The objective of the study is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands. Additional objectives are to monitor the incidence and reversibility of neuropathy during treatment, to assess the patient's Quality of life when treated with nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating metastatic pancreatic cancer.

The TRUST, a prospective, non-interventional observational single arm study with Nab-paclitaxel + Gemcitabine (NG) in pancreas carcinoma in the Netherlands, was started in 2015 to observe and register the daily use of Nab-paclitaxel. The primary objective was to prospectively assess safety of NG in metastatic pancreatic cancer under routine clinical practice. One of the major secondary objectives was to assess the influence of treatment with Nab-paclitaxel + Gemcitabine on the quality of life. The goal was to include 200 patients within a period of two year and collect their prospective data.

The study has included 44 patients in the period between October 2015 and October 2017. Of these patients, 41% were diagnosed with metastasized disease. 54% was diagnosed with local disease of which 18% was resectable and 36% was locally advanced. 73% of the patients with metastasized disease were treated with NG.

Over 70% of all NG treated patients received this treatment as a fist line of care. 21% of these patients had locally advanced pancreatic cancer. 20% of the patients had had a previous systemic treatment. Of all NG treated patients, 66% had an ECOG performance status of 0 or 1 and 62% of the patients was 75 years or younger.

At the time the study was terminated, 6 out of the 44 patients were still treated. 14 patients had stopped treatment due to disease progression, 8 patients had stopped due to adverse events and 7 patients had chosen to stop treatment.

The low inclusion rate, which led to a prospective study duration of 10 years, and the heterogenicity of the study population have led to the decision to terminate the study. Therefore, no analysis, apart from the detailed description of the study population above, can be performed.

All patients involved have taken the time to participate in the study and have filled out questionnaires. We would like to express our gratitude towards these patients.

We remain convinced that quality of life is an important parameter in pancreatic cancer which should be taken into consideration in daily care of patients.

A Study to Assess Clinical an Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Route Clinical Practice Treating Pancreatic Cancer

Non-interventional Observational Post-authorization Study to Assess Clinical and Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Routine Clinical Practice Treating Pancreatic Cancer (TRUST)

Survival is defined as the time from the first dose of nab-paclitaxel in combination with gemcitabine date to the date of death (any cause).

Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible.

The instrument contains 20 questions evaluating sensory, motor, and autonomic symptoms, and has been validated as an assessment tool for CIPN. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.

The instrument contains 30 questions evaluating quality of life in cancer patients.

A generic Quality of Life (QOL) instrument to measure and evaluate health status outcomes. The 3 Level (3L) version describes general health based on five distinct dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 Levels (indicating no problem, some or moderate problem and extreme problem).

Descriptive analysis of incidence and severity of neuropathy according to physicians assessment

The time to decrease of neuropathy to Gr ≤1 using the NCI CTCAE grading scale.

Per hospital, one generalized questionnaire will be filled in to evaluate the use of utilized resources when treating metastatic pancreatic cancer within routine clinical practice.

Celgene

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Sarcoma

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Ifosfamide

Isophosphamide mustard

Trabectedin

The administration of chemotherapy regimen with trabectedin will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.

This includes other palliative chemotherapy or biological therapy or best supportive care.

A J Gelderblom, Prof

This is an observational, non-randomized, open label, multicenter, phase IV study, which aims to reflect a real-life practice routinely used for the management of advanced soft tissue sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive these drugs in the Netherlands. This study pretends to reflect the use and schedule of chemotherapy regimen with trabectedin and/or other conventional care regimens such as other palliative chemotherapy/biological therapies or best supportive care (BSC) in the management of advanced soft tissue sarcoma patients in the clinic based at the discretion of the Investigator.

There are no pre-defined limits of administered cycles of trabectedin treatments or chemo- and/or biological therapy; thus, those treatments may continue as long as deemed necessary by the Investigator

* This phase IV study is designed to evaluate, in a real-world setting, usage patterns and associated outcomes associated with the anticancer treatment and/or best supportive care in the clinical practice. The primary study analysis will be to collect clinical data on symptomatic and best response, including tumor control rate, survival, TTP and PFS. Other endpoints of the study will include an evaluation of on-study subsequent anticancer treatments, QoL evaluation by using the EORTC QoL test (QLQ-C30) and an economic cost-effectiveness analysis by using the EQ-5D test.
* The study population will consist of patients with advanced soft tissue sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive these drugs. To be enrolled in this study, the patients must meet all inclusion criteria and none of the exclusion criteria. Estimated 100 patients will be enrolled.
* Inclusion Criteria

  1. Patients of both sexes with histologically diagnosed advanced soft tissue sarcoma after failure of anthracyclines and/or ifosfamide or patients unsuited to receive these drugs.
  2. Patients must have signed an informed consent document indicating that they understand the purpose and procedures required for the study, and that they are willing to participate in the study.
  3. Age ≥ 18 years. Exclusion Criteria Withdrawal of the informed consent at any point of the study will exclude the patient from the study.
* Assigned Intervention

  1. Trabectedin treatment The administration of chemotherapy regimen with trabectedin will be determined by the Investigator's discretion depending on the patients´ conditions and previous chemotherapy.
  2. Other conventional care regimens: other palliative chemotherapy or biological therapy or best supportive care. Patients on the other conventional care regimens could receive the following preselected treatments options:

A.Palliative chemotherapy or biological therapy (such as Ifosfamide or other anticancer agents with antitumor effect) as a palliative systemic therapeutic modality that may be offered to the patient with advanced soft tissue sarcoma.

B.Best supportive care, as a palliative therapeutic modality that may be offered to the patient with soft tissue sarcoma excluding chemotherapy/biological therapy but including radiotherapy and non-anticancer medication. Hence, this includes nutritional support, analgesics, antibiotics, antiemetic, transfusions, appetitive stimulants, antidepressants or any other symptomatic therapy, palliative surgery and/or psychological support and/or deep relaxation therapy. Localized radiotherapy to alleviate symptoms (i.e., pain) will be allowed, provided that the total delivered dose is within a palliative range. All therapies with potential systemic antitumor effect were excluded as BSC definition

* Subsequent Anticancer Treatments Administered After chemotherapy discontinuation, patients with documented progressive disease (PD) may be treated with subsequent anticancer therapies or best supportive care at the Investigators´ discretion. All subsequent treatments, surgical procedures or radiotherapy will be reported in the CRF.
* The study period starts at study inclusion and will continue until treatment discontinuation, death or until the predefined date of April 2014, when a final analysis have to delivered to the Dutch authorities.
* Efficacy Evaluations: Symptomatic response and best response as per the Investigator, according to RECIST will be assessed. Tumor control rate (CR + PR + SD), TTP, PFS and OS will be also evaluated.

Study in Patients With Advanced Soft Tissue Sarcoma (STS) After Failure of Anthracyclines and/or Ifosfamide

An Observational, Multicenter, Open-label Study of the Management of Patients With Advanced Soft Tissue Sarcoma After Failure of Anthracyclines and/or Ifosfamide or Patients Unsuited to Receive These Drugs

PharmaMar

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lenalidomide

Jeroen Stevens, MSc

The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.

An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.

A Non-interventional Observational Post Authorization Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide (REVIEW)

Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible

Quality of life will be measured by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QL Q-C30) and EORTC QLQ-MY20

Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice

Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice

Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice

Clinical outcome will be measured using routine assessment criteria (i.e. IMWG)

Symptoms and General Pathology

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Leukemia, Myelomonocytic, Chronic

Myelodysplastic Syndromes

Bone Marrow Diseases

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Chronic Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Azacitidine

Jan Koedam, MSc

The study design is a prospective, non-interventional, observational single arm study.

A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites in the Netherlands. In all cases, the decision to treat the patient with azacitidine was already made prior to the decision to enter the subject into the study.

Recruitment will continue until end of June 2015, provided a minimum of 150 patients have been included in the study. When this date is reached, all patients on azacitidine will continue to be followed until the last patient enrolled has been followed for 12 months.

An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands

A Non-interventional Observational Post Authorization Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands (OCEAN)

Adverse events will be classified using the Medical Drug Regulatory Activities (MedDRA) classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible

The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire was used to assess health-related quality of life (HRQoL). In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning.

Hematologic Response according to the 2000 International Working Group (IWG) response criteria for Myelodysplastic Syndrome (MDS)

Overall hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin \<100g/L or RBC transfusion-dependent, platelet count \<100x10\^9/L or platelet transfusion dependent, absolute neutrophil count \<1.5x10\^9/L. Sponsor's determination was derived using clinically relevant data.

Denominator for progression/relapse after HI included participants who had achieved HI.

Time to Treatment Failure is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

Overall survival (OS) was assessed using the time between randomization and the date of death

Study title	NCT ID	Conditions	Eligibility	Organization
A Study to Assess Clinical an Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Route Clinical Practice Treating Pancreatic Cancer	NCT02670746	Pancreatic Neop...	18 Years -	Celgene
Study in Patients With Advanced Soft Tissue Sarcoma (STS) After Failure of Anthracyclines and/or Ifosfamide	NCT01299506	Soft Tissue Sar...	18 Years -	PharmaMar
An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.	NCT02528838	Multiple Myelom...	18 Years -	Celgene
An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands	NCT02891551	Myelodysplastic... Leukemia, Myelo... Leukemia, Myelo...	18 Years -	Celgene
Study in Patients With Advanced Soft Tissue Sarcoma (STS) After Failure of Anthracyclines and/or Ifosfamide	NCT01299506	Soft Tissue Sar...	18 Years -	PharmaMar
An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.	NCT02528838	Multiple Myelom...	18 Years -	Celgene
An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.	NCT02528838	Multiple Myelom...	18 Years -	Celgene

Spots Global Cancer Trial Database for netherlands

Every month we try and update this database with for netherlands cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for netherlands

Every month we try and update this database with for netherlands cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for netherlands cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.