Clinical trial · Interventional
Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis
Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis
- 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)
Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally advanced or metastatic disease. Important to mention the number of patients that progress or recur in central nervous system (CNS). It has been reported that patients with adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with prophylactic cranial irradiation (PCI) is the standard of care in patients without progression after locoregional or systemic treatment because the proven benefit in overall survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able to prove any survival benefit, only in CNS PFS, probably because there is no trial, to our knowledge, of PCI in NSCLC that include only the specific group of patients considered in high risk of developing brain metastasis.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic Cranial Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A Prophylactic Cranial Irradiation
- description
- Patients will received PCI 25 Gy in 10 fractions WBRT 4 weeks after initial treatment in the absence of disease progression.
- interventionNames
- Radiation: Prophylactic Cranial Irradiation
- type
- NO_INTERVENTION
- label
- B Observation Group
- description
- Patients in this arm will be observed (not receiving WBRT)
Primary outcomes (1)
- measure
- Cumulative incidence of brain metastases
- timeFrame
- 24 months
- description
- From the day of randomization to the date when brain metastasis develop if this is the case.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically proven advanced NSCLC (Stage IIIB or IV) including wild-type, EGFR-mutated or ALK-rearrangements who received treatment and were without progression at the end. * Above 18 years * General status with a Karnofsky \>80% * Eastern Cooperative Group (ECOG) ≤2 * Negative CNS MRI at the beginning of any treatment * Carcinoembryonic antigen \> 20 pg * Hepatic and hematic cytology test within normal range * Adequate renal function * Those who accepted to participate in the study and who sign the letter of informed consent. Exclusion Criteria: * Patients with another type of cancer * Patients who refuse participate in the protocol * General status with a Karnofsky \<80% * Eastern Cooperative Group (ECOG) \>2 * Previous treatment with WBRT * Previous treatment with chemotherapy * Disease progression after initial treatment, either chemotherapy or chemoradiotherapy depending the case. * CNS metastasis at diagnosis * Abnormal laboratory test that interfere with chemotherapy or TKI administration
References
Publications (1)
- DERIVEDArrieta O, Maldonado F, Turcott JG, Zatarain-Barron ZL, Barron F, Blake-Cerda M, Cabrera-Miranda LA, Cardona AF, de la Garza JG, Rosell R. Prophylactic Cranial Irradiation Reduces Brain Metastases and Improves Overall Survival in High-Risk Metastatic Non-Small Cell Lung Cancer Patients: A Randomized phase 2 Study (PRoT-BM trial). Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1442-1450. doi: 10.1016/j.ijrobp.2021.02.044. Epub 2021 Feb 25. PMID 33640422