Clinical trial · Interventional
Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas
- 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)
Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.
Conditions
Conditions (2)
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 |
| Gliomas | Glioma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metronomic Therapy Cohort
- description
- Concurrent temozolomide and radiotherapy plus lose dose of temozolomide
- interventionNames
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- Dose-Dense Therapy Cohort
- description
- Concurrent temozolomide and radiotherapy plus high dose of temozolomide
- interventionNames
- Drug: Temozolomide
Primary outcomes (1)
- measure
- 12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic evidence of a malignant glioma. * Tissue block or unstained slides must be available for MGMT analysis. * Age 18-70 * KPS \> 50 * Granulocyte count \>1.5 X 109/L * Platelet count \>99 X 109/L * SGOT \< 2.5X upper limit of normal (ULN). * Serum creatinine \< 2X ULN. * Bilirubin \< 2X ULN. * All patients must sign written informed consent. Exclusion Criteria: * Any prior chemotherapy, radiotherapy and biologic therapy for glioma. * Any prior experimental therapy for glioma. * Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin). * Serious medical or psychiatric illness that would in the opinion of the investigator would interfere with the prescribed treatment. * Pregnant or breast feeding women. * Refusal to use effective contraception.
References
Publications (0)
Data not yet available