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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN45209900 |
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Date of registration:
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23/09/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised study of radiotherapy and concomitant Temodal® (temozolomide) or neoadjuvant chemotherapy followed by radiotherapy and concomitant Temodal® in patients with high grade glioma
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Scientific title:
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A multicentre, phase III, randomised controlled trial of radiotherapy and concomitant Temodal® (temozolomide) or neoadjuvant chemotherapy followed by radiotherapy and concomitant Temodal® in patients with high grade glioma |
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Date of first enrolment:
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13/01/2003 |
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Target sample size:
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143 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN45209900 |
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Study type:
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Interventional |
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Study design:
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Multicentre prospective phase III randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Denmark
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Finland
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Norway
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Sweden
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Roger
Henriksson |
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Address:
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Radiumhemmet
Karolinska sjukhuset i Solna
171 74
Stockholm
Sweden |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Written informed consent
2. Histologically proven astrocytic glioma (grade III: AA or grade IV: GBM)
3. Age 18 - 60 years
4. Performance status WHO 0-2
5. Life expectancy > 3 months
6. Normal organ function, except if abnormal due to tumour involvement as indicated by:
6.1. Platelet count (TPK) < 100 x 10^9/L
6.2. Haemoglobin (Hb) > 90 g/L
6.3. Neutrophils: < 1.5 x 10^3/mm3 or LPK < 3.0 x 10^9/L
6.4. Serum creatinine and bilirubin < 1.5 times the upper limit of normal (ULN)
6.5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 3 x ULN
7. Men and women of child bearing potential must be using adequate contraception
Exclusion criteria: 1. Prior chemotherapy or radiotherapy for malignant glioma
2. Any other active malignancies within the last 5 years, except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ
3. Pregnancy or breast feeding
4. Any condition (medical, social, psychological) which would prevent adequate information and follow up
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Grade III (anaplastic astrocytoma) or grade IV (glioblastoma multiforme) tumours
Cancer
Malignant neoplasm of brain
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Intervention(s)
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Patients will be randomised to receive either
1. Conventional radiotherapy and temozolomide:
60 Gy radiotherapy is administered in 2 Gy fractions over 6 weeks, concomitantly with daily doses of temozolomide 75 mg/m2
2. Neoadjuvant temozolomide 2-3 cycles followed by radiotherapy
3 cycles of temozolomide dosage 200 mg/m2 days 1-5 in a 28 days schedule, with radiologic evaluation before start of treatment and after 2 cycles. If progression is noted cycle 3 is omitted. Radiotherapy is administered in the same way as for the standard treatment arm.
Follow up for both treatment arms is 1 ond 3 months after end of treatment.
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Primary Outcome(s)
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Overall survival
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Secondary Outcome(s)
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1. Safety, all adverse events are collected
2. Quality of Life (QoL), evaluated by the EORTC QLQ-30 before start of treatment, then 12 and 24 months after start of treatment.
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Source(s) of Monetary Support
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Nordic Clinical Brain Tumour Study Group (Sweden)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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