Clinical trial · Observational
Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)
Temodal Capsule All-Case-Registered Surveillance (Designated Drug Use Investigation) - Evaluation of The Safety and Efficacy of Temodal in Patients With Newly Diagnosed Malignant Glioma (Concomitant With Radiotherapy and Then as Monotherapy) and Relapsed Malignant Glioma (as Monotherapy)
- 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)
The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
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 |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy (for patients with newly diagnosed malignant glioma) | Radiation | — | UNRESOLVED |
| Temozolomide (for newly diagnosed malignant glioma) | Drug | Temozolomide | ALIAS |
| Temozolomide (for relapsed malignant glioma) | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Newly diagnosed patients
- description
- Patients treated with temozolomide for newly diagnosed malignant glioma
- interventionNames
- Drug: Temozolomide (for newly diagnosed malignant glioma)
- Radiation: Radiotherapy (for patients with newly diagnosed malignant glioma)
- label
- Relapsed patients
- description
- Patients treated with temozolomide for relapsed malignant glioma
- interventionNames
- Drug: Temozolomide (for relapsed malignant glioma)
- label
- Newly diagnosed anaplastic astrocytoma patients
- description
- Patients treated with temozolomide for newly diagnosed anaplastic astrocytoma
- interventionNames
- Drug: Temozolomide (for newly diagnosed malignant glioma)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * All patients treated with temozolomide for newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy). Exclusion Criteria: * Patients with a history of hypersensitivity to temozolomide or dacarbazine. * Pregnant women and women who may be pregnant.
References
Publications (0)
Data not yet available