Clinical trial · Interventional
Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer
A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
NCT00080938CI-TRIAL-00067689completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide and Radiation
- description
- Temozolomide:administered orally. Radiation: whole brain radiation therapy
- interventionNames
- Drug: Temozolomide
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Number of Patients With Intracranial Response
- timeFrame
- assessed every cycle while on treatment, then every 3 months for 2 years
- description
- Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer (NSCLC), including the following histologies: * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma * Bronchoalveolar carcinoma * All variants of NSCLC * At least 1 bidimensionally measurable brain metastasis * Confirmed by MRI within the past two weeks, and computed tomography (CT) scan is not acceptable * Biopsy is not required * Not eligible for surgical resection or radiosurgery of brain metastasis * Systemic disease not in immediate need of chemotherapy * Age\>=18 years * ECOG Performance status of 0-1 * More than 12 weeks of life expectancy * Adequate hematologic, renal, and liver function as demonstrated by laboratory values performed within two weeks, inclusive, prior to administration of study drug or registration * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Bilirubin ≤ 2 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (5 times ULN if liver metastases are present) * Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present) * Creatinine ≤ 1.6 mg/dL * Fertile patients must use effective contraception * Prior biologic therapy allowed * More than 4 weeks since prior chemotherapy * Prior radiotherapy for local control or palliative therapy for painful bony lesions allowed * Prior surgery for brain metastasis allowed * At least 4 weeks since prior radiotherapy to ≥ 15% of bone marrow (2 weeks for \< 15% of bone marrow) and recovered * No prior radiotherapy to ≥ 50% of bone marrow * Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated Exclusion Criteria: * HIV positive * AIDS-related illness * Poor medical risks due to active nonmalignant systemic disease * Frequent vomiting * There is medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) * Pregnant or nursing * Prior temozolomide * Prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion * Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy * Other concurrent investigational agents * Other concurrent treatment for brain metastasis * Other concurrent chemotherapy during study radiotherapy * Concurrent growth factors to induce elevations in blood counts for the purposes of administration of study drug at scheduled dosing interval or to allow treatment with study drug at a higher dose
References
Publications (0)
Data not yet available
No reference posted for this study.