Clinical trial · Interventional
Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)
A Randomized, Open-Label Phase 2 Study of Temozolomide Added to Whole Brain Radiation Therapy Versus Whole Brain Radiation Therapy Alone for the Treatment of Brain Metastasis From Non-Small Cell Lung Cancer
NCT00076856CI-TRIAL-00027435completedPhase 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)
The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival
Secondary outcomes (1)
- measure
- Time to radiological CNS progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Age greater than or equal to 18 * Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) * At least one brain metastasis diagnosed within 30 days of randomization * Brain metastases must not have been previously treated with WBRT or radiosurgery * No more than 2 sites of extracranial metastases * May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites * Meets protocol requirements for specified laboratory values. * Written informed consent and cooperation of patient * Appropriate use of effective contraception if of childbearing potential. * Karnofsky Performance Status KPS greater than 70 * Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)
References
Publications (1)
- RESULTChua D, Krzakowski M, Chouaid C, Pallotta MG, Martinez JI, Gottfried M, Curran W, Throuvalas N. Whole-brain radiation therapy plus concomitant temozolomide for the treatment of brain metastases from non-small-cell lung cancer: a randomized, open-label phase II study. Clin Lung Cancer. 2010 May;11(3):176-81. doi: 10.3816/CLC.2010.n.022. PMID 20439193