Others are gastrointestinal nausea and vomiting , pain at the site of injection and vasculitis. Aseptic meningitis is a common side effect of intrathecal MTX. It begins 2 to 4 hr after the drug is injected and lasts for 12 to 72 hours. Acute encephalopathy, seizures, have also been reported.
Transverse myelopathy is a rare complication of intrathecal chemotherapy with both MTX and Cytarabine. Statistical considerations Progression-free, overall and median survival will be measured from the date of the start of the treatment. Patients with progressive disease during treatment, as defined by neurological deterioration together with radiological progression, will go off study and further treatment will be given according to the local policy. All patients registered in this study will be followed until death to determine survival. To calculate the sample size a Minimax 2-stage procedure is applied Simon R.
Controlled Clinical Trials The first interim look will be after 31 patients are evaluated for response. If of these 31 patients less than 16 patients have a complete response, the trial will be stopped and the treatment regimen will be considered uninteresting.
Otherwise another 19 patients can be entered in the study. The treatment regimen will be considered effective and thus ready for further investigation in a Phase III study if at least 30 out of 50 patients will respond. Quality of life assessment: Although the assessment of QL is usually not performed in a phase II study, it was decided that since no empirical data exist on the QL under this treatment in this population of patients, to explore the impact of treatment related side-effects on the overall quality of life. Analysis of these data will be entirely exploratory and descriptive in nature.
In this study, the EORTC core questionnaire QLQ-C30 30 questions and a brain cancer specific module 20 questions will be used in the patients own language , which are both well validated and accepted instruments to measure various domains that constitute quality of life. The symptom scales include questions related to fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhoea, financial impact, headache, seizures, drowsiness hair loss, itching skin, leg weakness and bladder control.
A proxy should be 18 years of age or older and should have a close relationship with the patient, i. In case of proxy rating, this should be indicated on the questionnaire. In patients with stable disease, the QL assessment should discontinue upon starting another treatment.
Pathology review All histological material, after being examined by the local institute pathologist, must be sent to the central pathologist. In addition, immunophenotyping data are required according to the guidelines given on the pathology forms.
In case of doubt, the central pathologist may request frozen material to repeat the immunophenotypical analysis. The diagnosis made by the local pathologist of the participating centres will be accepted for registration. The local pathologist are requested to use the Working Formulation classification appendix 3. The central pathologist is: Independent data monitoring committee and cost evaluation None Computerised and manual consistency checks will be performed on newly entered forms; queries will be issued in case of inconsistencies.
Consistent forms will be validated by the data manager to be entered on the masterbase. Inconsistent forms will be kept "on hold" until resolution of the inconsistencies. Patient protection The responsible investigator will ensure that this study is conducted in agreement with either the declaration of Helsinki Tokyo, Venice and Hong-Kong amendments , or the laws and regulations of the country, whichever provides the greatest protection of the patient. Subject identification The name of the patient will not be asked for nor recorded at the data centre. A sequential identification number will be automatically attributed to each patient registered in the trial.
This number will identify the patient and must be included an all case report forms. In order to avoid identification errors, patients initials maximum of 4 letters , date of birth and local chart number if available will also be reported on the case report forms. They will be informed as to the strict confidentiality of their patient data, but that their medical records may be reviewed for trial purposes by authorised individuals other than their treating physician. An example of a patient informed consent statement is given as an appendix to this protocol. This will not prejudice the patient's subsequent care.
Documented informed consent must be obtained for all patients included in the study before they are registered at the EORTC Data Centre. This must be done in accordance with the national and local regulatory requirements. This implies that "consent must be documented either by the subject's dated signature or by the signature of an independent witness who records the subject's assent". Investigator commitment statement Investigators will be authorised to register patients in this trial only when they have returned to the Data Centre: This form also contains a statement about any possible conflict of interest.
Registration from centres not yet included on the authorisation list will not be accepted. Administrative responsibilities The study co-ordinators in co-operation with the Data Centre will be responsible for reviewing all case reports forms and documenting his review on evaluation forms, discussing the contents of the reports with the Data Manager and the Statistician, and for publishing the study results.
He will also be responsible for answering all clinical questions concerning eligibility, treatment, and the evaluation of the patients. Bernard Verbeeten Instituut P. Insurance within the European Union: When specific requirements are stated in the national laws of the E. For countries where there are no specific requirements, the EORTC provides an insurance coverage which is valid for two years after a patient has completed the treatment strategy being studied by the research protocol.
This insurance programme covers the EORTC as the promoter, the investigators and all local hospital staff. Insurance outside the European Union: Publication Policy The final publication of the trial results will be written by the study co-ordinators on the basis of the statistical analysis performed at the EORTC Data Centre.
The Data Centre report will be completed no later than 6 months after the last patients has discontinued therapy. A draft manuscript will be submitted by the study co-ordinator to the data centre for review no later than three months after receiving the Data Centre report. After revision by the Data Centre and other co-authors the manuscript will be sent to a major scientific journal. All publications, abstracts or presentations including data from the present trial will be submitted for review to the EORTC Data Centre at least two weeks prior to submission for abstracts, and four weeks prior to submission of manuscripts and slides for presentation.
No information can be used for publication or oral presentation without the written agreement of the trial co-ordinators. Administrative signature The responsible investigator in this hospital: List of participants Most members of the Lymphoma Co-operative Group showed interest in this study. Immunophenotypic profile of CNS lymphoma: J Neurooncol ; 7: J Clin Oncol ; Multivariate analysis of prognostic factors with non HIV-related primary cerebral lymphoma.
A proposal for a prognostic scoring. Br J Cancer ; Proc Am Soc Clin Oncol ; A regimen of high-dose chemotherapy and radiotherapy in non-Hodgkin's cerebral lymphoma occurring in immunocompetent patients. Analysis of primary cerebral lymphomas treated in 10 centers in France between and A retrospective study from the federation nationals des centres de lutte contre le cancer. The CSR protocol for primary cerebral non-Hodgkin's lymphomas: Chemotherapy as first treatment for primary malignant non-Hodgkin's lymphoma of the central nervous system. J Neurol ; Management of primary cerebral lymphoma with initial chemotherapy: Primary central nervous system lymphoma: J Neurooncol ; Neurology ; 44 suppl Neurobehavioral sequelae of cranial irradiation in adults: Combined modality therapy for primary CNS lymphoma.
Primary Central Nervous System Lymphoma. Recent Adv Cancer Res April Current management of primary central nervous system lymphoma. Combined therapy for primary central nervous system lymphoma in immunocompetent patients. Eur J Cancer ; 31A: Primary Central Nervous System a review. Ann Intern Med ; High-dose methotrexate for non-AIDS primary central nervous system lymphoma. J Neurosurg ; Preirradiation methotrexate chemotherapy of primary central nervous system lymphoma: Primary central nervous system lymphoma in Japan.
Prescribing, recording, and reporting photon beam therapy. Primary central nervous system lymphomas - new pathological developments. Primary and secondary lymphomas of the central nervous system - a clinicopathological study of 52 cases with presentation of very rare one Proc Int Conf on Malignant Lymphoma Lugano June Incidence, clinicopathological features and outcome of primary central nervous system lymphomas.
Population-based data from a Danish lymphoma registry. Ann Oncol ; 5: Cyclophosphamide, doxorubicin, vincristine, and prednisone for primary central nervous system lymphoma: Ten years of treatment experience at the UCSF. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol ; 8: Primary T cell non-Hodgkin's lymphoma of the central nervous system.
Case report and review of the literature. Acta Haematol ; Primary Central Nervous System Lymphoma: Pathology with clinical correlations of primary central nervous system non-Hodgkin's lymphoma: The Massachusetts General Hospital experience Primary malignant lymphoma of the central nervous system: Non-Hodgkin's lymphoma of the brain: J Clin Oncol ; 9: Primary central nervous system non-Hodgkin's lymphoma: Measurements of Blood-Brain Barrier permeability in patients undergoing radiotherapy and chemotherapy for primary cerebral lymphoma.
Eur J Cancer ; Patient characteristics associated with high-risk Methotrexate concentrations and toxicity. Preirradiation chemotherapy with Cyclophosfamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: J Clin Oncol ; 14 2: Primary Lymphoma of the Central Nervous System. An unresolved therapeutic problem. Chemotherapy in the management of intraocular lymphoma.
National Cancer Institute sponsored study of classification of non-Hodgkin's lymphomas: A propos de 20 cas. J Eur Radiother ; 7: Prolonged remission of primary central nervous system lymphoma after discontinuation of steroid therapy. Primary central nervous system lymphoma. J Neuro-Oncol ; Primary malignant lymphoma of the brain. A report of 24 cases from the Norwegian Radium Hospital.
Acta Oncol ; Clinical and histopathologic diagnosis. Neurological function status Grade Function 1 Able to work or to perform normal activities; neurological findings minor or absent 2 Able to carry out normal activities with minimal difficulties. Neurological impairment does not require nursing care or hospitalisation. Requiring nursing care or hospitalisation. Patients confined to bed or wheelchair, or have significant intellectual impairment. Requiring hospitalisation and constant nursing care and feeding. Patients unable to communicate or in coma.
The palliation of brain metastases: Radiotherapy The individually shaped facial blocks should protect the anterior part of the eye and the ENT region. Care should be taken not to shield the leptomeninges and the posterior part of the eye. The lateral corners of the eyelids on each side has to be marked with a lead mark. The frontal border of the radiation fields or the block to be cut lies at this mark. If needed, a slight gantry rotation can be used to superimpose marks at both eyes and to correct for the diverging edge of the beam.
While drawing the blocks, particular attention is to be given on the caudal inferior border at the base of the middle cranial fossa where a margin from at least 1 cm should be respected. The caudal border of the radiation field is situated in between the second and third cervical vertebra. The use of a posterior block, shielding the soft tissues of the neck, is allowed.
Name 3 objects, taking 1 second to say each. Then ask the patient all 3 after you have said them 1 point for every correct object. Then, repeat the objects until the patient has learned all 3. Give 1 point for each correct answer. Stop after 5 answers. Ask for names of 3 objects learned in question 3. Give I point for each correct answer. Point to a pencil and watch. Have the patient name them as you point. Have the patient repeat "no ifs, and, or buts".
Fold the paper in half. Put the paper on the floor. Have the patient read and obey the following: Have the patient write a sentence of his or her own choice. The sentence should contain a subject and an object and should make sense. Ignore spelling errors when scoring. Enlarge the design printed below to 2 cm per side and have the patient copy it. Give 1 point if all the sides and angles are preserved and the intersecting sides form a hexagonal. We are interested in some things about you and your health. Please answer all of the questions yourself by circling the number that best applies to you.
There are no "right" or "wrong" answers. The information that you provide will remain strictly confidential. Please fill in your initials: Your birthday Day, Month, Year: Today's date Day, Month, Year: Do you have any trouble doing strenuous activities, like carrying a heavy shopping bag or a suitcase?
Do you have any trouble taking a long walk? Do you have any trouble taking a short walk outside of the house? Do you have to stay in a bed or a chair for most of the day? Do you need help with eating, dressing, washing yourself or using the toilet? Were you limited in doing either your work or other daily activities?
Were you limited in pursuing your hobbies or other leisure time activities? Were you short of breath? Have you had pain? Did you need to rest? Have you had trouble sleeping? Have you felt weak? Have you lacked appetite? Have you felt nauseated?
Have you been constipated? Have you had diarrhoea? Did pain interfere with your daily activities? Have you had difficulty in concentrating on things, like reading a newspaper or watching television? Did you feel tense? Did you feel irritable? Did you feel depressed? Have you had difficulty remembering things?
Has your physical condition or medical treatment interfered with your family life? Has your physical condition or medical treatment interfered with your social activities? Has your physical condition or medical treatment caused you financial difficulties? How would you rate your overall health during the past week? How would you rate your overall quality of life during the past week? Did you feel uncertain about the future? Did you feel you had setbacks in your condition? Were you concerned about disruption of family life? Did you have headaches?
Did your outlook on the future worsen? Did you have double vision?
Was your vision blurred? Did you have difficulty reading because of your vision? Did you have seizures? Did you have weakness on one side of your body? Did you have trouble finding the right words to express yourself'.? Did you have difficulty speaking? Did you have trouble communicating your thoughts? Did you feel drowsy during the daytime? Did you have trouble with your coordination?
Did hair loss bother you? Did itching of your skin bother you? Did you have weakness of both legs? Did you feel unsteady on your feet?
Did you have trouble controlling your bladder? Letter for patient information English version: You have got a disease which is called "non-Hodgkin-lymphoma of the brain". It is a serious illness, for which treatment usually consists of a combination of chemotherapy and radiotherapy. The goal of the treatment is on one hand the amelioration of the existing signs and symptoms and one the other hand the prevention of a recurrence of the disease. The proposed treatment consists of 2 cycles of chemotherapy followed by radiotherapy.
Total treatment time will be approximately 3 months. Both cycles of chemotherapy consist of the administration of several drugs, some of them intravenous and other orally. Also, several lumbar punctures will have to be done to bring the drugs directly into the cerebrospinal fluid. Of course, drugs to prevent or reduce nausea and vomiting will be given also.
In between the 2 courses, a short resting period is foreseen, as well as before starting radiotherapy. Radiotherapy consists of about twenty irradiations of the brain, spread over four weeks. The most common side effects encountered during treatment are nausea, vomiting and mucositis.
If you have got these or other complaints, do not hesitate to inform your physician in charge. Advice and, if necessary, supplementary drug treatment will be provided in order to relieve the symptoms. Other possible side effects are deterioration of the function of the kidneys and the brain. Some of these problems might only become distinct after some time.
All the drugs which will be given to you are well known for several years and are in use over the entire world by numerous teams. They are tested and approved by the National Health Care Institutes.
The dose of the drugs will be individualised depending on some biological characteristics. The best combination of the drugs for optimal results in your disease is not yet defined. No existing combination has clearly been proven to be superior. For this reason your physician has proposed you to take part in an international European study where the efficacy and toxicity of the schedule called "MBVP" is tested. Every patients which has been asked to participate fulfils to a number of criteria which have been defined beforehand. All information concerning your disease, its treatment and the obtained results will be collected and analysed with respect to the rules of privacy.
This data will be, in an anonymous form, only accessible to your own physician and to the physicians, data managers and other collaborators which are involved in the study. Of course, you are free to participate in this study. Click here Would you like to report this content as inappropriate? Click here Do you believe that this item violates a copyright? Your recently viewed items and featured recommendations. View or edit your browsing history.
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