Clinical trial · Interventional
Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM
Phase I/II Randomized Prospective Trial for Newly Diagnosed GBM, With Upfront Gross Total Resection, Gliadel®, Followed by Temodar® With Concurrent IMRT Versus GK
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): met stopping rules for futility
Summary
Brief summary (as posted)
A glioblastoma (GBM) is the most common malignant primary brain tumor, yet it is not easy to control. Recent studies show that survival improves for patients who get aggressive surgery to remove a tumor before starting radiation (RT) and chemotherapy (chemo) treatment. Surgery, RT and chemo are part of regular cancer care for GBM. RT is usually done in daily doses 5 days a week over about 6 weeks. Beams of radiation are aimed at the tumor site plus some of the normal brain tissue around the tumor area. GammaKnife® (GK) radiosurgery also delivers radiation but in a larger dose over one day. GK sends beams to a precise target (tumor location) and very little normal brain tissue that is nearby. This study will compare GK treatment to the usual RT treatment after surgery, and with chemo. We want to know: * How well each treatment keeps the tumor from growing back. * What the effects (good and bad) of the treatments are. * How you rate your quality of life. * How the treatment affects your ability to think, understand, reason, and remember. * How you rate your ability to think, understand, reason, and remember. * If using a certain type of MRI scan can show the difference between new tumor growth and changes caused by treatment. * If certain features found in tumor cells can help doctors predict how tumors will respond to treatment.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GammaKnife(R) stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
| Gross total resection and Gliadel(R) wafers implanted | Procedure | — | UNRESOLVED |
| Standard fractionated radiation therapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GammaKnife(R) stereotactic radiosurgery
- description
- Following surgery for Gross total resection and Gliadel(R) wafers implanted , the patient will receive a one-day GammaKnife(R) stereotactic radiosurgery procedure and will also take temozolomide (Temodar(R)) chemotherapy daily for six weeks with a one month break before taking temodar for additional 12 monthly cycles.
- interventionNames
- Procedure: Gross total resection and Gliadel(R) wafers implanted
- Radiation: GammaKnife(R) stereotactic Radiosurgery
- Drug: Temozolomide
- type
- ACTIVE_COMPARATOR
- label
- Standard fractionated radiation therapy
- description
- Following surgery for Gross total resection and Gliadel(R) wafers implanted , the patient will receive six weeks of standard fractionated radiation therapy plus daily temozolomide (Temodar(R)) chemotherapy for six weeks. This is followed by a one month break before taking temodar for additional 12 monthly cycles.
- interventionNames
- Procedure: Gross total resection and Gliadel(R) wafers implanted
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * single enhancing lesion of the brain with MRI appearance consistent with GBM * Must be appropriate for Gliadel® wafer implant * Pathologic confirmation of GBM * no gross residual tumor found on the immediate postoperative MRI scan * Volumetric measurements of the resection cavity margin being \< 50 cc * Karnofsky performance status (KPS) 80% or better * Must be able to undergo MRI imaging with gadolinium * Willingness to have follow up visits at Barrow Neurological Institute(BNI) Exclusion Criteria: * multi-focal tumors * tumors which extend across the corpus callosum, * residual nodular disease * Tumors, with a contraindication to Gliadel® implant, such as an anticipated extensive ventricular opening resulting from complete resection. * Tumor measuring greater than 50cc in volume (on post-operative scan) Volume \< 50 cc if volume if a significant volume of eloquent tissue is included in the proposed treatment volume * Unable to undergo MRI with gadolinium * History of cancer within 2 years of GBM diagnosis (basal and squamous cell skin cancers are allowed) * Patient is not willing to follow up at BNI
References
Publications (0)
Data not yet available