Clinical trial · Interventional
Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC
Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.
NCT01282437CI-TRIAL-00017459NVALT11completedPhase 3ClinicalTrials.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)
For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.
Conditions
Conditions (3)
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 Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Radical Treatment | — | UNRESOLVED | — |
| Stage III Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic Cranial Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prophylactic Cranial Irradiation
- interventionNames
- Radiation: Prophylactic Cranial Irradiation
- type
- NO_INTERVENTION
- label
- Observation
- description
- Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm.
Primary outcomes (1)
- measure
- Proportion of patients developing symptomatic brain metastasis
- timeFrame
- 24 months after randomisation
Secondary outcomes (3)
- measure
- Time to develop neurological symptoms (confirmed or unconfirmed by imaging)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology) * Whole body FDG-PET-scan before start of therapy available: No distant metastases * CT or MRI of the brain before the start of radical therapy available: No brain metastases * Platinum-based chemotherapy is mandatory * Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery * Radiotherapy dose without surgery at least a biological equivalent of 60Gy * No prior cranial irradiation * Patients must sign a study-specific informed consent at the time of registration Exclusion Criteria: * The opposite of the above
References
Publications (1)
- DERIVEDWitlox WJA, Ramaekers BLT, Joore MA, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder G, Haitjema T, Ubbels JF, Lagerwaard J, El Sharouni SY, Stigt JA, Smit EF, van Tinteren H, van der Noort V, Groen HJM, De Ruysscher DKM. Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study. Radiother Oncol. 2020 Mar;144:65-71. doi: 10.1016/j.radonc.2019.10.016. Epub 2019 Nov 14. PMID 31733490