Clinical trial · Interventional
Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer
A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Nonprogressive on Gefitinib or Erlotinib
- 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 to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| gefitinib | Drug | Gefitinib | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| whole-brain radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Time to symptomatic brain metastases
Secondary outcomes (5)
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Safety and tolerability of prophylactic cranial radiotherapy
- measure
- Psycho-neurological effects of prophylactic cranial radiotherapy
- measure
- Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed non-small cell lung cancer
* Stage IIIB or IV disease
* Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
* At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
* Stable disease allowed provided 1 of the following criteria is met:
* EGFR mutation (exon 19 or 21)
* Having ≥ 2 of the following 3 factors:
* Female
* Never smoked
* Histologically confirmed adenocarcinoma of the lung
* No evidence of brain metastases by CT scan or MRI within the past 4 weeks
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 150,000/mm\^3
* Bilirubin \< 1.5 mg/dL
* Serum creatinine \< 1.5 times upper limit of normal
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Received 1 or 2 prior systemic chemotherapy regimensReferences
Publications (0)
Data not yet available