ISRCTN81470623CompletedNot Applicable
A multicentre randomised active controlled study comparing two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma
ordic Clinical Brain Tumor Study group (Sweden)0 sites342 target enrollmentStarted: March 3, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 342
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Age > 60
- •2. Performance Status (PS) 0-2 according to the WHO definition. Patients with a general condition corresponding to WHO 0-2, but due to physical handicap are graded as PS 3 or 4 can also be included.
- •3. Patients with histologically/cytologically confirmed glioma grade 3-4 or 4
- •4. Expected to tolerate all three treatment options
- •5. Life expectancy of at least 3 months
- •6. General organ function allowing chemotherapy as indicated by:
- •6.1. Neutrophiles > 1.5 x 109/l
- •6.2. Platelets > 100 x 109/l
- •6.3. Haemoglobin > 10 g/dl (100g/l)
- •6.4. Serum creatinine and bilirubin < 1.5 times upper normal limit
- •6.5. Aspartate Aminotransferase (ASAT), alanine Aminotransferase (ALAT) < 3 times upper normal limit
- •7. No other medical condition likely to interfere with treatment or the assessment of its efficacy
- •8. Patient is on the lowest steroid dose, which gives optimal functional improvement
- •9. Written informed consent
Exclusion Criteria
- •1. Patients with other primary cancer, with the exception of radically treated squamous or basal cell carcinoma of the skin or other curatively treated malignancy without relapse 2 years after diagnosis
- •2. PS WHO grade 3-4, except for patients with a general condition corresponding to WHO 0-2, but due to physical handicap are graded as PS 3 or 4
- •3. Any other medical condition which, in the view of the investigator, is a contraindication to inclusion in the study
- •4. Chemotherapy, biological therapy, radiotherapy or immunotherapy given previously for brain tumour or within 3 years for other malignancy
- •5. Radiotherapy to the head, which would interfere with giving radiotherapy treatment for brain tumour
Investigators
Similar Trials
Active, not recruiting
Not Applicable
A multi-center study to assess the safety, effectiveness and tolerance of a study drug FTY720 in patients with certain types of the eye disease uveitis (inflammation in the back of the eye).veitis, intermediateuveitis, posterioruveitis, pan.MedDRA version: 14.1Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersEUCTR2011-004160-30-DEovartis Pharma Services AG30
Active, not recruiting
Phase 1
A multi-center study to assess the safety, effectiveness and tolerance of a study drug FTY720 in patients with certain types of the eye disease uveitis (inflammation in the back of the eye).EUCTR2011-004160-30-GBovartis Pharma Service AG
Active, not recruiting
Phase 1
A study to compare how safe and well tolerated study drug Abelacimab (MAA868) is comapred to another drug called Rivaroxaban in patients with heart condition that causes an irregular and abnormally fast heart rate.MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersAtrial FibrillationEUCTR2020-004507-13-CZAnthos Therapeutics1,200
Active, not recruiting
Phase 1
A study to compare how safe and well tolerated study drug Abelacimab (MAA868) is comapred to another drug called Rivaroxaban in patients with heart condition that causes an irregular and abnormally fast heart rate.MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersAtrial FibrillationEUCTR2020-004507-13-HUAnthos Therapeutics1,200
Active, not recruiting
Phase 1
A study to compare how safe and well tolerated study drug Abelacimab (MAA868) is comapred to another drug called Rivaroxaban in patients with heart condition that causes an irregular and abnormally fast heart rate.MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersAtrial FibrillationEUCTR2020-004507-13-PLAnthos Therapeutics1,200