Clinical trial · Interventional
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-center Randomized Phase ⅢTrial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): this trial enroll extremely slow and No funding support
Summary
Brief summary (as posted)
1. Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI. 2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) . 3. The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).
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 |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prophylactic WBRT
- description
- Take the whole brain radiotherapy radiotherapy
- interventionNames
- Radiation: Radiotherapy
- type
- NO_INTERVENTION
- label
- Observer Group
- description
- The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale.
Primary outcomes (1)
- measure
- The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .
- timeFrame
- 2.5years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy 2. No previous history of radiotherapy and surgery of brain 3. Agree to radiotherapy 4. age \> 18 and \<75 years 5. ECOG performance status 1 or less 6. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB\>=80g /DL) functions 7. Have provided informed consent Exclusion Criteria: 1. Seizure cannot be controled by the drugs 2. Combined with other disease of the brain such as tumour or infarction 3. Hypersensitivity to MR enhancer
References
Publications (0)
Data not yet available