Clinical trial · Interventional
Radiation Therapy Combined With Either Gefitinib or Temozolomide in Pats With NSCLC and Brain Metastases
Whole Brain Radiotherapy in Combination With Gefitinib (Iressa) or Temozolomide (Temodal) for Brain Metastases From Non-Small Lung Cancer (NSCLC) A Randomized Phase II Trial
NCT00238251CI-TRIAL-00007065completedPhase 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)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with either gefitinib or temozolomide may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving radiation therapy together with either gefitinib or temozolomide works in treating patients with non-small cell lung cancer and brain metastases.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients undergo whole-brain radiotherapy (WBRT) once daily on days 1-5 and 8-12 and receive oral gefitinib once daily on days 1-28. Gefitinib treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
- interventionNames
- Drug: gefitinib
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients undergo WBRT as in arm I and receive oral temozolomide once daily on days 1-21. Temozolomide treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
- interventionNames
- Drug: temozolomide
- Radiation: radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer AND newly diagnosed brain metastases meeting 1 of the following criteria: * Multiple brain metastases * Single brain metastasis not amenable to potentially curative treatment * No advanced extracranial disease severely compromising vital functions and performance PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Hemoglobin \> 10 g/dL * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of documented bone metastases) * No unstable or uncompensated hepatic disease that would preclude study participation Renal * Creatinine clearance ≥ 40 mL/min * No unstable or uncompensated renal disease that would preclude study participation Cardiovascular * No myocardial infarction within the past 3 months * No unstable or uncompensated cardiac disease that would preclude study participation Pulmonary * No clinically active interstitial lung disease * Patients with chronic stable radiographic changes who are asymptomatic eligible * No other unstable or uncompensated respiratory disease that would preclude study participation Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after completion of study treatment * No nausea, vomiting, inability to swallow whole tablets/capsules, or malabsorption syndrome that would preclude oral medication ingestion or absorption * No psychiatric disorder that would preclude giving informed consent or study compliance * No active infection * No uncontrolled diabetes mellitus * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior temozolomide Endocrine therapy * Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 4 days before study entry Radiotherapy * No prior brain irradiation Surgery * Not specified Other * No prior gefitinib or erlotinib * More than 30 days since prior investigational clinical trial participation * No other concurrent experimental drugs * No other concurrent anticancer therapy * No concurrent treatment with any of the following: * Phenytoin * Carbamazepine * Rifampin * Barbiturates * Hypericum perforatum (St. John's wort) * Other enzyme-inducing anti-epileptic drugs or tuberculostatic treatments * Any drug that contraindicates administration with study drugs
References
Publications (1)
- RESULTPesce GA, Klingbiel D, Ribi K, Zouhair A, von Moos R, Schlaeppi M, Caspar CB, Fischer N, Anchisi S, Peters S, Cathomas R, Bernhard J, Kotrubczik NM, D'Addario G, Pilop C, Weber DC, Bodis S, Pless M, Mayer M, Stupp R. Outcome, quality of life and cognitive function of patients with brain metastases from non-small cell lung cancer treated with whole brain radiotherapy combined with gefitinib or temozolomide. A randomised phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 70/03). Eur J Cancer. 2012 Feb;48(3):377-84. doi: 10.1016/j.ejca.2011.10.016. Epub 2011 Nov 15. PMID 22093943