Additional identifiers
EudraCT number
2010-022496-66
ClinicalTrials.gov number
NCT01310868
Protocol/serial number
9566
Study information
Scientific title
An evaluation of the tolerability and feasibility of combining 5-Amino-Levulinic Acid (5-ALA) with carmustine wafers (Gliadel) in the surgical management of primary Glioblastoma (GALA-5 Trial)
Acronym
GALA-5
Study hypothesis
Glioblastoma (GBM) is the commonest brain tumour in adults. The combination of surgical cytoreduction (removal of the tumour), concomitant chemoradiation (chemotherapy given at the same time as radiotherapy) and adjuvant chemotherapy (chemotherapy given after the chemoradiotherapy leads to a median survival of 15 months and 2 year survival of 27%.
Aminolevulinic acid hydrochloride (5-aminolevulinic acid HCl; 5ALA;
Gliolan) is a prodrug that leads to the selective accumulation of the fluorescent compound protoporphyrin IX (PPIX) in GBM. This can be visualised under blue light enabling objective surgical resection and improved progression free survival.
Carmustine wafers (Gliadel) are biodegradable copolymer discs impregnated with the alkylating agent carmustine that are implanted into the resection cavity at the end of surgery. They have a modest impact on survival of GBM patients but have yet to be evaluated in combination with fluorescence guided resection.
The aim of this study is to establish the safety, tolerability and feasibility of combining fluorescence-guided surgical tumour resection with intraoperative chemotherapy in GBM patients eligible to proceed onto chemoradiotherapy.
Patients with suspected primary GBM in whom complete resection is considered feasible will be given 5-ALA. They will then receive carmustine implants.
A protocol summary can be downloaded from the trial website: http://www.ctc.ucl.ac.uk/TrialDetails.aspx?TrialID=50
More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9566
Ethics approval
10/H0304/100
Study design
Non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Brain Tumour; Disease: Brain and Nervous System
Intervention
1. 60 patients are required to receive both Gliolan and Gliadel wafers for the trial
2. The trial will stop recruiting once 60 patients have received both treatments
3. The global sample size has been set at 120 patients on the portfolio to account for a 50% rate of failure to administer Gliadel wafers (e.g to patients with complications or those who are found to be ineligible during surgery)
4. 5-ALA (Gliolan) used to guide resection
5. Gliadel wafers are inserted into tumour cavity at the end of resection
Intervention type
Drug
Phase
Phase II
Drug names
Gliolan, Gliadel
Primary outcome measure
1. % 5-ALA resected patients receiving Carmustine wafers
2. Post operative complication rate
3. No. patients with delay (> 6 weeks) to receiving chemoRT due to surgical complications
4. No. patients failing to receive chemoRT due to surgical complications
5. No. patients failing to complete chemoRT without interruption
6. % patients with a lower WHO performance status after surgery with Carmustine wafers
Secondary outcome measures
1. Time to Clinical Progression
2. Survival at 24 months
Overall trial start date
01/05/2011
Overall trial end date
01/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The patient is reviewed at a specialist neuro-oncology multi-disciplinary team (MDT).
2. Preop MRI should be carried out, ideally on no or stable steroids according to RANO criteria
3. Imaging is evaluated by a neuro-radiologist and judged to have typical appearances of a primary GBM
4. Radical resection is judged to be realistic by the neurosurgeons at the MDT (i.e. NICE criteria for the use of Carmustine wafers can be met)
5. WHO performance status 0 or 1
6. Age ≥18
7. Patient judged by MDT to be fit for standard radical aggressive therapy for GBM (resection followed by RT with concomitant and adjuvant temozolomide)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 120
Participant exclusion criteria
1. GBM thought to be transformed low grade or secondary disease
2. The patient has not been seen by a specialist MDT.
3. There is uncertainty about the radiological diagnosis
4. 5-ALA or Carmustine wafers is contra-indicated (inc known or suspected allergies to 5-ALA or porphyrins, or acute or chronic types of porphyria)
5. Pregnant or lactating women
6. Known or suspected HIV or other significant infection or comorbidity that would preclude radical aggressive therapy for GBM
7. Active liver disease (ALT or AST ≥5 x ULRR)
8. Concomitant anti-cancer therapy except steroids
9. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years
10. Previous brain surgery (including biopsy) or cranial radiotherapy
11. Platelets <100 x109/L
12. Mini mental status score <15
Recruitment start date
01/05/2011
Recruitment end date
01/05/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK & UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Gower Street
London
WC1E 6BT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Samantha Dickson Brain Tumour Trust
Alternative name(s)
SDBTT
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list