Clinical trial · Interventional
Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer
Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer
NCT02605811CI-TRIAL-00037846unknownPhase 2ClinicalTrials.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)
To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Carcinoma | Carcinoma | CURATED_BROADER | 0.78 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prophylaxis cranial radiotherapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- temozolomide
- description
- temozolomide oral 150mg/m2 d1-5/28d for 12 cycles
- interventionNames
- Drug: temozolomide
- type
- ACTIVE_COMPARATOR
- label
- prophylaxis cranial radiotherapy
- description
- prophylaxis cranial radiotherapy,25-30Gy/10Fra
- interventionNames
- Radiation: prophylaxis cranial radiotherapy
Primary outcomes (1)
- measure
- 2-year incidence of brain metastases
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological or cytological diagnosis of small-cll lung cancer histology 2. 18 years or older 3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2 4. Local stage SCLC without distant metastases 5. After 1st-line chemotherapy (EP or IP) at least 4 cycles 6. After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy 7. CR or PR assessment by RECIST(1.0) before randomized 8. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L 9. Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases 10. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula) Exclusion Criteria: 1. Mixed non-small cell lung cancer histology 2. Neck and supraclavicular lymph node metastasis 3. Be allergic to temozolomide or intolerable to radiotherapy 4. Any unstable systemic disease 5. Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.