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Markers of Aggressive Local Therapy In Newly diagnosed Glioblastomas

Not Applicable
Completed
Conditions
Glioblastomas
Cancer
Malignant neoplasm of brain
Registration Number
ISRCTN62033854
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
145
Inclusion Criteria

1. Imaging appearances of a high grade glioma
2. Likely to be suitable for radiotherapy (60 Gy) with concomitant and adjuvant temozolomide
3. World Health Organization (WHO) performance status (PS) grade 0 or 2
4. Aged 18 - 75 years, either sex
5. Resection or biopsy (although only those suitable for maximal resection will be considered for the MALTING Trial)

Patients for the MALTING Trial will be felt by their consultant neurosurgeon to be suitable for 5-aminolevulinic acid (5-ALA) fluorescence-guided resection with insertion of carmustine wafers.

Exclusion Criteria

1. Unsuitable for a contrast-enhanced MRI (MR unsafe metallic implants, claustrophobia, allergy to gadolinium contrast agent or severe renal impairment)
2. Pregnant
3. Allergic to aminolevulinic acid
4. Suffering from porphyria. Care will be taken if the patient is taking other photosensitising drugs.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pattern of contrast enhancement at first recurrence. This will be assessed by co-registering anatomical MR's at recurrence with pre-RT and highlighting areas of new contrast enhancement. Invasive GBM's will be defined as radiological evidence of > 80% of the recurrent tumour occurring outside the radiotherapy 95% isodose. For the MALTING study, the percentage of patients surviving 2 years will be the main outcome measure.
Secondary Outcome Measures
NameTimeMethod
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