All Drugs and Chemicals

Immunomodulating Agents

Immunologic Factors

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

Immunotherapeutic Agent

Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

Molecular Target

The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy.

Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.

The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent:

* I: Molecular targeted agent
* II: Immunotherapy

Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy

Efficacy will be determined in terms of overall responses according to standard practice by the local investigator. Disease and response assessments are defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Overall survival is defined as the time from the date of inclusion to the date of death from any cause or to the date of last follow-up (in exceptional cases where it is impossible to document the date of death). Every effort should be made to document the cause of death.

Progression free survival (PFS) will be measured from the date of inclusion to the date of progression or death, whatever the cause.

Progression will be defined according to the RECIST criteria.

Objective tumor response will be measured according to the RECIST 1.1 criteria.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Elise Deluche, M.D

Deluche Elise, MD

Lavau-Denes Sandrine, MD

The objective of this study is to show the interest of setting up a drug vigilance card in Oncology in order to reinforce patient safety, develop compliance and avoid drug interactions when the patient consults town professionals or other specialists.

Recent developments in oral chemotherapy and targeted therapies have radically changed cancer patient management; ambulatory care is now common. Oral therapies afford many advantages, improving patient quality of life and autonomy by reducing hospital stays and involving patients in their own care. Optimising the care of cancer patients at home requires the coordinated intervention of hospital and town healthcare professionals and involvement of the patient to detect, prevent, and manage adverse events, avoid drug interactions, and educate patients. Preliminary work in haematology has highlighted (n = 31 patients) the interest of a "drug vigilance card" in three indications (Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukaemia and Multiple Myeloma) with an increase in the town-hospital link.

This is an prospective cohort study. Following the announcement consultation, in addition to the personalised care plan, the information about the treatment will be contained in a drug monitoring card that will be given to the patient by the health professional (doctor or nurse). This drug monitoring card should be presented to the health professionals by the patient. During the entire period of treatment, the patient will have a card.

Onco-haematology Vigilance Card

Impact of an Onco-haematology Vigilance Card in the Optimisation of the Town-hospital Relationship.

Patient satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)

Caregiver satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)

patients will have to answer shorts questions on GIRERD\* questionnaire to evaluate their Medication compliance to oral anticancer drugs.

\*X. Girerd, O. Hanon, K. Anagnostopoulos, C. Ciupek, J.J. Mourad, S. Consoli Assessment of antihypertensive compliance using a self-administered questionnaire: development and use in a hypertension clinic Presse Med, 30 (2001), pp. 1044-1048

Treating physicians ad health professionnals satisfaction will be evaluated using IBM computer usability satisfaction questionnaires published by James R. Lewis (https://doi.org/10.1080/10447319509526110)

The use of the QR code with be evaluated by counting how many times it will be flashed during study period.

University Hospital, Limoges

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Immune System Diseases

Nervous System Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Hypersensitivity

Carcinoma

Brain Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

Crizotinib

Erlotinib Hydrochloride

Gefitinib

Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors)

Brain Radiotherapy (stereotactic radiotherapy was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain )was used for more than 3 intracranial lesions);Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors)

if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）

molecular targeted therapies

SRS was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain)was used for more than 3 intracranial lesions

Brain Radiotherapy

Liu Anwen, Phd

Cai Jing, Phd

Anwen Liu, MD

Brain metastasis is the most common neurological complication in tumor patients, and lung cancer is the most common tumor with brain metastasis. The prognosis of patients with non-small cell lung cancer with brain metastasis is poor. If not treated, the median survival time was about 1 month, the median survival time for steroid therapy was about 2 to 3 months, and the median survival time for patients receiving whole brain radiotherapy was about 3 to 6 months. Studies have shown that the incidence of brain metastasis is not only related to tumor size, N stage and tumor cell type, but also more likely to occur in NSCLC patients with sensitive gene mutation. With the rapid development of NSCLC molecular targeted therapy and precise radiotherapy, the new main therapeutic methods for NSCLC brain metastasis in recent years include stereotactic radiotherapy for (SRT),. Based on intensity modulated technique, simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain) and molecular targeted therapy were carried out. However, at present, the best treatment choice for NSCLC brain metastasis, especially for asymptomatic brain metastasis patients, is still controversial. The choice and combined application mode of individualized treatment for different patients is still a problem to be explored. Based on the synergistic effect of radiotherapy and molecular targeted therapy on the basis of cell and molecule, The purpose of this study was to prospectively compare the efficacy of radiotherapy combined with targeted therapy and targeted therapy alone in patients with asymptomatic NSCLC brain metastasis with gene sensitive mutations, and subgroup analysis of different molecular targets and mutation sites. It is expected that this study will provide a basis for optimizing the curative effect of patients with NSCLC brain metastasis.

This is a randomized phase II clinical trial. The objective of the study is to assess efficacy and safety of brain radiotherapy combined with targeted therapy and simple targeted therapy in patients with asymptomatic NSCLC brain metastasis with gene sensitive mutation. Patients were randomized with equal allocation to Molecular targeted therapy alone or with brain radiotherapy. Study therapy continued until disease progression, unacceptable adverse event, or withdrawal of consent

The Role of Brain Radiotherapy in Patients With Asymptomatic Brain Metastasis in the Era of Targeted Therapy for NSCLC

A Randomized Phase II Trial of Brain Radiotherapy Combined With Targeted Therapy in Patients With Asymptomatic NSCLC Brain Metastasis With Gene Sensitive Mutation

time from the beginning of study to death due to any cause or last follow-up

Time from BM diagnosis to the first documentation of intracranial lesion progression or death with documented intracranial progression

ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)

The period from the start of treatment to the progression or death of a patient

the cumulative survival rate is 0.5, the corresponding survival time means that only 50% of the individuals can live through this time.

Number of patients with adverse events (AEs) as a measure of safety and tolerability

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy	NCT03835520	Cancer	Immunotherapeut... Molecular Targe...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Onco-haematology Vigilance Card	NCT04931329	Medical Oncolog... Hematology Molecular Targe...		-	University Hospital, Limoges
The Role of Brain Radiotherapy in Patients With Asymptomatic Brain Metastasis in the Era of Targeted Therapy for NSCLC	NCT04193007	Non Small Cell ... Brain Metastase...	molecular targe... Brain Radiother...	18 Years - 80 Years	Second Affiliated Hospital of Nanchang University
Onco-haematology Vigilance Card	NCT04931329	Medical Oncolog... Hematology Molecular Targe...		-	University Hospital, Limoges

Spots Global Cancer Trial Database for molecular targeted therapies