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Health Condition(s) or Problem
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Topic: National Cancer Research Network; Subtopic: Brain Tumour; Disease: Brain and Nervous System
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Lay Summary
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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. Primary outcomes will include neurosurgical complications and evaluation of time to start and complete radiotherapy and chemotherapy. Secondary outcome measures will be survival at 24 months and time to progression. (from UKCRN Portfolio)
Additional lay summaries...
http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-5ala-and-gliadel-wafers-as-part-of-treatment-for-glioblastoma-gala5 (from ISRCTN)
RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells
that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery
with 5-ALA given together with Gliadel wafer, followed by radiation therapy and
temozolomide, in treating patients with primary glioblastoma.
(from ClinicalTrials.gov)
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Who can enter the trial
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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)
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Who cannot enter the trial
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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
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What will happen
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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
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Primary aim
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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
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Secondary Aim
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1. Time to Clinical Progression
2. Survival at 24 months
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Participant Information Sheet
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Not available in web format, please use the contact details below to request a patient information sheet
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Website
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http://www.ctc.ucl.ac.uk/TrialDetails.aspx?TrialID=50
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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