Clinical trial · Interventional
Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer
NCT01518621CI-TRIAL-00037588RadErterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation | Radiation | — | UNRESOLVED |
| Radiation plus erlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy alone
- description
- Total brain irradiation, 3Gy x10
- interventionNames
- Radiation: Radiation
- type
- EXPERIMENTAL
- label
- Radiation plus erlotinib
- description
- Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation
- interventionNames
- Drug: Radiation plus erlotinib
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: * Newly diagnosed multiple brain metastases not suitable for first-line chemotherapy * Relapsed NSCLC with newly diagnosed multiple brain metastases * Relapsed NSCLC after second-line or more chemotherapy regimens with newly diagnosed multiple brain metastases * Diagnosis of brain metastases confirmed by MRI (or CT if MRI is not available/possible) within the past 4 weeks * Symptoms attributable to brain metastases * Patients who have undergone craniotomy with incomplete resection are eligible * Clinician's opinion that whole-brain radiotherapy (WBRT) will be beneficial * ECOG PS 0-2 * Age above 18 years * Serum bilirubin \< 2 times upper limit of normal (ULN) * AST and ALT \< 2 times ULN (\< 5 times ULN if liver metastases are present) * Creatinine \< 1.5 times ULN * Able to take oral medication * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons Exclusion Criteria: * More than 3 sites (organ systems) of extracranial metastases * Evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy * Evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
References
Publications (0)
Data not yet available
No reference posted for this study.