Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02605811

Enrollment

426

Registered

2015-11-16

Start date

2015-09-30

Completion date

2021-12-31

Last updated

2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Carcinoma, Small Cell Lung Cancer

Keywords

limited small cell lung cancer, brain metastases, prophylactic cranial radiotherapy, temozolomide

Brief summary

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.

Detailed description

We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.

Interventions

DRUGtemozolomide

RADIATIONprophylaxis cranial radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
2-year incidence of brain metastases	2 year

Countries

China

Contacts

Primary ContactHaihong Yang, MD

bjrf2009@yahoo.com862083062825

Backup ContactHaihng Yang, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026