Clinical trial · Interventional
Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma
Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma: Comparison of Two Established Schedules
NCT04019262CI-TRIAL-00091161active not recruitingPhase 1 / Phase 2ClinicalTrials.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)
This is a prospective, randomized, open-label, exploratory trial of temozolomide-based chemo-radiotherapy which compares two widely used established radiation schedules with either 40 Gy in 15 fractions or 25 Gy in 5 fractions with concurrent temozolomide for both schedules in patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Temozolomide Oral Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 40 Gy in 15 fractions
- description
- Patients randomized to 40 Gy in 15 fractions will receive 75 mg/m\^2 temozolomide per day for 15 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m\^2 for upto 1 year.
- interventionNames
- Radiation: Radiation Therapy
- Drug: Temozolomide Oral Product
- type
- ACTIVE_COMPARATOR
- label
- 25 Gy in 5 fractions
- description
- Patients randomized to 25 Gy in 5 fractions will receive 150 mg/m\^2 temozolomide per day for 5 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m\^2 for upto 1 year.
- interventionNames
- Radiation: Radiation Therapy
- Drug: Temozolomide Oral Product
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Each patient must meet all of the following inclusion criteria for study enrollment: * Age ≥18 with ability to provide written informed consent * Pathologically confirmed WHO Grade IV Gliobastoma prior receiving radiotherapy * Prior radiotherapy to a dose of ≥50Gy * No signs of distant metastases * Baseline laboratory assessment including CBC and blood chemistry, ANC \> or equal 1500, Platelet count greater or equal 100. Liver function tests and creatinine not greater than twice ULN. * Patient should not be pregnant. Urine or blood β-HCG within 14 days prior to study start for females who are not atleast one year post-menopausal or who have ot undergone a surgical sterilization procedure * A baseline MRI scan of the brain is required to determine how much tumor is present for properly planning patient's radiotherapy. * Karnofsky Performance Status (KPS) below 60 or ECOG of 3 or 4 * Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team). Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible for enrollment: * Evidence of distant metastases on any staging or imaging modality * Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study) * Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator. * Karnofsky Performance Status less than 50 * Prior radiotherapy to involved site in brain.
References
Publications (0)
Data not yet available
No reference posted for this study.