CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
5-ALA +4 moredrug
Likely dose
Concomitant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist 75mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01310868
NCT01310868Phase 2Completed
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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)

University College, London·interventional·Posted Mar 9, 2011·Updated Oct 5, 2017

In Brief

A Phase 2 clinical trial evaluating 5-ALA, Gliadel wafers, and 3 other interventions for Glioblastoma. Completed, enrolled 59 participants across 10 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2011
Enrollment StartMay 1, 2011
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.3 years ago

Interventions

5-ALAdrug

5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers

Gliadel wafersdrug

The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection.

Radiotherapy as normal based on standard clinical protocols determined by the neuro-oncologistradiation

60Gy in 30 fractions (2Gy per fraction given once daily, five days per week (Monday-Friday) over 6 weeks. Radiotherapy delivered to gross tumour volume with 2-3cm margin. Standard treatment following neurosurgery for glioblastoma

Concomitant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologistdrug

temozolomide given alongside the radiotherapy at 75mg/m2 daily from the first day of radiotherapy, until the last day of radiotherapy, but for no longer than 49 days. Standard treatment following neurosurgery for glioblastoma

Adjuvant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologistdrug

Following a 4 week break after contomitant chemo/RT, temozolomide given 150-200mg/m2 TMZ 5/28 days for 6 cycles (dosage increase to 200mg/m2 on second and subsequent cycles dependent on haematological toxicity. Sites should follow local guidelines if different.). TMZ to be given on 5 consecutive days followed by 23 days with no TMZ, per cycle. Standard treatment following neurosurgery and concomitant chemo/RT for glioblastoma