Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

Phase 2

• Conditions: Small Cell Lung Cancer; Metastatic Carcinoma
• Interventions: Drug: temozolomide; Radiation: prophylaxis cranial radiotherapy

• Registration Number: NCT02605811
• Lead Sponsor: Guangzhou Medical University

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-12
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-16
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-28
• Primary Completion: 2019-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 426

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
temozolomide	temozolomide	temozolomide oral 150mg/m2 d1-5/28d for 12 cycles
prophylaxis cranial radiotherapy	prophylaxis cranial radiotherapy	prophylaxis cranial radiotherapy,25-30Gy/10Fra

Primary Outcome Measures

Name	Time	Method
2-year incidence of brain metastases	2 year

Trial Locations

Locations (1)

The first affiliated hospital of Guangzhou MC; 🇨🇳 Guangzhou, Guangdong, China