Clinical trial · Interventional
Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001)
- 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)
RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer
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 Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib /Gefitinib | Drug | — | UNRESOLVED |
| Prophylactic cranial irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- prophylactic cranial irradiation
- description
- Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
- interventionNames
- Radiation: Prophylactic cranial irradiation
- Drug: Erlotinib /Gefitinib
- type
- ACTIVE_COMPARATOR
- label
- Conctrol
- description
- Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity
- interventionNames
- Drug: Erlotinib /Gefitinib
Primary outcomes (1)
- measure
- The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
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 2. NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy 3. No previous history of radiotherapy and surgery of brain 4. good response( CR/PR) to Erlotinib or Gefitinib. 5. Agree to radiotherapy 6. age \> 18 and \<75 years,ECOG performance status 1 or less 7. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB\>=80g /DL) functions 8. 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