Clinical trial · Interventional
Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED)
Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy Followed by Sequential TMZ in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Central Nervous System (CNS) Metastasis Versus Radiotherapy Alone
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Patient target could not be reached within the planned timeframe.
Summary
Brief summary (as posted)
This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide and radiotherapy | Drug | — | UNRESOLVED |
| Whole brain radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy with temozolomide and radiotherapy
- interventionNames
- Drug: Temozolomide and radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy alone
- interventionNames
- Procedure: Whole brain radiotherapy
Primary outcomes (1)
- measure
- Number of Participants With Progression-free Survival (6 Month)
- timeFrame
- 6 months
- description
- The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as \<25% increase in tumor size on CT or MRI.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prior histologic confirmation of non-small cell lung cancer (NSCLC). * Optional: NSCLC histologic confirmation of metastasis of NSCLC. * Presence of unidimensionally measurable disease in the brain. * No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin. * Age: \>18 years. * Subjects must not have systemic disease that in the opinion of the investigator is in immediate need of chemotherapy * Karnofsky Performance status \>=70%. * Absolute neutrophil count (ANC) \>1,500/mm\^3, platelets \>100,000/mm\^3, hemoglobin \>8 g/dL. * Serum creatinine and bilirubin \<1.5 times upper normal limit of testing laboratory. * Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) \<3 times upper limit of testing laboratory. * Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable. * Prior neurosurgery \>2 weeks from initiating treatment with temozolomide. * Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with temozolomide. * Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception. * Written informed consent. Exclusion Criteria: * Chemotherapy or biologic therapy within four weeks prior to initiating therapy with temozolomide. * Prior radiation therapy for brain \<4 weeks from initiating therapy with temozolomide. * Surgery within two weeks prior to temozolomide administration. * Recursive Partitioning Analysis (RPA) class III * Patients with a single brain metastasis amenable to radiosurgery of resection * Known Human Immunodeficiency Virus (HIV) disease. * Acute infection requiring intravenous antibiotics. * Any reason making compliance to the protocol improbable.
References
Publications (0)
Data not yet available