Condition category
Cancer
Date applied
21/06/2011
Date assigned
21/06/2011
Last edited
16/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Fiona Dungey

ORCID ID

Contact details

Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

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 measures

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

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

http://www.ucl.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/02/2016: No publications found, verifying study status with principal investigator