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NCT06014450
Prophylactic Cranial Irradiation Versus Observation in Stage IV NSCLC Randomized Controlled Clinical Study
NA trial testing Prophylactic Cranial Irradiation for experiment arm in Prophylactic Cranial Irradiation, Cumulative Incidence of Brain Metastases in 144 participants. Status unknown.
1 August 2025
Quick facts
| Lead sponsor | Guizhou Medical University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 144 |
| Start date | 1 September 2023 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 August 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Prophylactic Cranial Irradiation for experiment arm
Conditions studied
- Prophylactic Cranial Irradiation, Cumulative Incidence of Brain Metastases — all drugs for Prophylactic Cranial Irradiation, Cumulative Incidence of Brain Metastases →
Sponsor
Guizhou Medical University
Who can join
Adults 18 to 80, any sex, with Prophylactic Cranial Irradiation, Cumulative Incidence of Brain Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lung cancer has remained the leading cause of cancer-related deaths worldwide. An important and frequent cause of morbidity in this patient group is the development of brain metastases (BM). Lung cancer represents the leading cause of BM, and previous reports have shown that approximately 40% of patients will develop BM throughout their disease. Additionally, due to the improved use of advanced imaging techniques as part of routine initial staging. Another factor to consider is the considerably prolonged survival in patients with lung cancer as a direct result of the medical advances that have improved systemic disease control in the past 2 decades. The development of BM has recognized as one of the most detrimental factors for patient prognosis, with a negative impact on quality of life (QoL), concomitant neurocognitive disorders, and, importantly, a significant decrease in OS. RTOG 0214 shows that In patients with stage III disease without progression of disease after therapy, PCI decreased the rate of BM. NVALT-11/DLCRG-02 Study shows that PCI significantly decreased the proportion of patients who developed symptomatic brain metastases with an increase in low-grade toxicity. In conclusion, PCI improved DFS and decreased the risk of BM in patients with LA-NSCLC.Recent studies suggest NSCLC, including stage IV NSCLC, PCI significantly decreased CBM in addition to increasing progression-free survival and OS. At present, few studies on whether prophylactic radiation therapy can reduce the rate of brain metastasis and OS in stage IV NSCLC. In this randomized controlled study of stage IV NSCLC, we investigated whether PCI reduces the chance of brain metastases and whether it has a survival benefit.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT06014450
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- NCT05252065 — Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer · unknown
- NCT05176067 — Randomized Controlled Clinical Study of Drug Therapy Combined With Thoracic Radiotherapy for Non-oligometastatic NSCLC · NA · unknown
- NCT05150145 — Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06014450 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guizhou Medical University
- Last refreshed: 28 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06014450.
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