Clinical trial · Interventional
IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
IMRT Combined With Erlotinib Compared With Whole-brain Radiotherapy for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
NCT02556593CI-TRIAL-00038101terminatedPhase 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)
This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.
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 |
|---|---|---|---|
| Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib | Drug | Erlotinib | ALIAS |
| IMRT | Radiation | — | UNRESOLVED |
| WBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMRT & erlotinib
- description
- Patients in experimental group receive IMRT and erlotinib: Daily IMRT(45Gy in 15 fractions) to the brain metastases with daily erlotinib(150mg.po) for three weeks
- interventionNames
- Radiation: IMRT
- Drug: erlotinib
- type
- ACTIVE_COMPARATOR
- label
- whole-brain radiotherapy
- description
- Patients in this group receive WBRT at 30Gy in 10 fractions
- interventionNames
- Radiation: WBRT
Primary outcomes (1)
- measure
- CNS progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed NSCLC and wild type EGFR * 4-10 brain metastases on high quality CT scanning or MRI. * No previous EGFR-TKI treatment. * No previous brain radiotherapy. * More than 4 weeks from last chemotherapy. * Expected Survival of at least 2 months. * KPS≥ 70 * RTOG RPA performance status 0-1 * Lab tests should meet these criteria: White blood cell count ≥3×10\^9 /L;Platelet count≥100×10\^9 /L;Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; Serum creatinine 1.5 times or less the ULN or creatinine clearance rate(CCR) greater than or equal to 60 ml/min. * Pregnancy test (-) * Be able to sign informed consent form. Exclusion Criteria: * With unstable systematical diseases (concluding acute infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, hepatopathy, nephropathy, metabolic diseases) * With metastases on meninges. * Taking antiepileptics (phenytoin sodium etc.) at the same time * Unable to oral medication. * Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
References
Publications (35)
- BACKGROUNDTsao MN, Lloyd N, Wong RK, Chow E, Rakovitch E, Laperriere N, Xu W, Sahgal A. Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD003869. doi: 10.1002/14651858.CD003869.pub3. PMID 22513917
- BACKGROUNDPesce 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
- BACKGROUNDHaie-Meder C, Pellae-Cosset B, Laplanche A, Lagrange JL, Tuchais C, Nogues C, Arriagada R. Results of a randomized clinical trial comparing two radiation schedules in the palliative treatment of brain metastases. Radiother Oncol. 1993 Feb;26(2):111-6. doi: 10.1016/0167-8140(93)90091-l. PMID 7681997
- BACKGROUNDDavey P, Hoegler D, Ennis M, Smith J. A phase III study of accelerated versus conventional hypofractionated whole brain irradiation in patients of good performance status with brain metastases not suitable for surgical excision. Radiother Oncol. 2008 Aug;88(2):173-6. doi: 10.1016/j.radonc.2008.05.020. Epub 2008 Jun 12. PMID 18555546
- BACKGROUNDRades D, Kieckebusch S, Lohynska R, Veninga T, Stalpers LJ, Dunst J, Schild SE. Reduction of overall treatment time in patients irradiated for more than three brain metastases. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1509-13. doi: 10.1016/j.ijrobp.2007.05.014. Epub 2007 Aug 6. PMID 17689033
- BACKGROUNDHendriks LE, Troost EG, Steward A, Bootsma GP, De Jaeger K, van den Borne BE, Dingemans AM. Patient selection for whole brain radiotherapy (WBRT) in a large lung cancer cohort: Impact of a new Dutch guideline on brain metastases. Acta Oncol. 2014 Jul;53(7):945-51. doi: 10.3109/0284186X.2014.906746. Epub 2014 Apr 23.