Clinical trial · Interventional
Radiation Boost for Newly Diagnosed Glioblastoma Multiforme
A Phase I/II Trial of Maximal Resection, Local Radiation Boost With Concomitant Temozolomide, Followed by External Radiation Therapy With Concomitant Temozolomide for the Treatment of Newly Diagnosed Glioblastoma Multiforme
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Loss of funding from sponsor
Summary
Brief summary (as posted)
The purpose of this study is to determine treatment related toxicity, tumor response, progression-free survival and quality of life of newly diagnosed Glioblastoma Multiforme (GBM) patients undergoing a combination of surgical resection, brachytherapy and external beam radiation with concomitant temozolomide, followed by adjuvant temozolomide.
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 Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Procedure | — | UNRESOLVED |
| External Beam Radiation Therapy | Procedure | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Treatment-related toxicity.
- timeFrame
- 1 year
Secondary outcomes (4)
- measure
- 6 month, 1 year and overall survival.
- timeFrame
- End of study
- measure
- Tumor progression.
- timeFrame
- End of study
- measure
- Progression-free survival.
- timeFrame
- End of study
- measure
- Quality of life.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, unifocal, unilateral, supratentorial lesion seen on MRI and suspicious for Glioblastoma Multiforme * Subject must be a candidate for surgical resection of the tumor mass with feasible gross total resection * Age 18 years or older * Subject must be an appropriate candidate to receive brachytherapy and temozolomide per the GliaSite RTS and temozolomide IFU * The tumor must be histopathologically confirmed by intra-operative frozen section and by final pathology * Karnofsky Performance Status (KPS) =\> 70 * Negative pregnancy test if a female of childbearing age and not surgically sterilized * Male or female subject agrees to use acceptable birth control methods while receiving treatment (if not surgically sterile) * Life expectancy \> 3 months * Adequate laboratory results: ANC =\> 1.5 x 109/L. Platelets =\> 100 x 109/L * Subject or legal representative must provide informed consent and HIPAA authorization prior to surgery Exclusion Criteria: * Prior use of temozolomide * Presence or history of severe hepatic or renal impairment * Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea and vomiting * Subject with prior intracranial malignancy * Major medical illness or psychiatric impairments that in the investigators opinion will prevent administration or completion of the protocol therapy * Subject has pacemaker or other MRI non-compatible metal in the body * Previous radiation to the head/neck or brain * Pregnant or lactating women * Patient has allergy to iodine and/or dacarbazine * Creatinine \> 1.5x upper limits of normal (ULN), AST \> 3x ULN * Chemotherapy within the last 6 months * Residual tumor \>1 cm (in a single dimension) on baseline MRI scan (T1 post-gadolinium images) * Balloon surface within 1 cm of critical structure (brain stem, midbrain, optic chiasm) on baseline MRI scan
References
Publications (0)
Data not yet available