Clinical trial · Interventional
Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma
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)
NCT01310868CI-TRIAL-00029787completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-ALA | Drug | — | UNRESOLVED |
| Adjuvant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist | Drug | — | UNRESOLVED |
| Concomitant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist | Drug | — | UNRESOLVED |
| Gliadel wafers | Drug | — | UNRESOLVED |
| Radiotherapy as normal based on standard clinical protocols determined by the neuro-oncologist | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-ALA and Gliadel wafers
- description
- This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.
- interventionNames
- Drug: 5-ALA
- Drug: Gliadel wafers
- Radiation: Radiotherapy as normal based on standard clinical protocols determined by the neuro-oncologist
- Drug: Concomitant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist
- Drug: Adjuvant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist
Primary outcomes (1)
- measure
- Safety, Tolerability, and Feasibility of Combination Intra-operative 5-ALA and Gliadel Wafers Prior to Adjuvant Radiotherapy Plus Temozolomide
- timeFrame
- Date of surgery to end of temozolomide and radiotherapy treatment (up to 34 weeks)
- description
- Procedure compliance: Proportion of 5-ALA resected patients who received Carmustine wafer implants (e.g to take into account rates of patients who did not receive Carmustine wafer implants due to 1) ventricular breach, 2) inaccurate peri-operative diagnosis, 3) intra-operative surgical decision) * Post-operative complication rate: Proportion of patients with a new post-operative deficit or surgical complication (wound infection, CSF leakage, intracranial hypertension) * No. of patients with chemoRT delay (i.e number who do not begin chemoRT 6 weeks after surgery) due to surgical complications\* * No. of patients failing to start chemoRT due to surgical complications rather than tumour progression * No. of patients failing to complete chemoRT without interruption (RT with concomitant chemotherapy, and RT with concomitant plus adjuvant chemotherapy) * Proportion of patients with a lower WHO performance status after surgery with Carmustine wafers (at first post-operative clinic visit)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA i. The patient is reviewed at a specialist neuro-oncology multi-disciplinary team (MDT). ii. Stealth MRI (neuronavigation) will be performed prior to surgery. iii. Imaging is evaluated by a neuro-radiologist and judged to have typical appearances of a primary GBM iv. 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) v. WHO performance status 0 or 1 vi. Age ≥18 vii. Patient judged by MDT to be fit for standard radical aggressive therapy for GBM (resection followed by RT with concomitant and adjuvant temozolomide) EXCLUSION CRITERIA i. GBM thought to be transformed low grade or secondary disease ii. The patient has not been seen by a specialist MDT. iii. There is uncertainty about the radiological diagnosis iv. 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) v. Pregnant or lactating women vi. Known or suspected HIV or other significant infection or comorbidity that would preclude radical aggressive therapy for GBM vii. Active liver disease (ALT or AST ≥5 x ULRR) viii. Concomitant anti-cancer therapy except steroids ix. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years x. Previous brain surgery (including biopsy) or cranial radiotherapy xi. Platelets \<100 x109/L xii. Mini mental status score \<15
References
Publications (0)
Data not yet available
No reference posted for this study.