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NCT02605811 Clinical Trial

Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02605811
Other study ID # GACA1501
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 2015
Est. completion date December 2021

Study information
Verified date March 2019
Source Guangzhou Medical University
Contact Haihong Yang, MD
Phone 862083062825
Email bjrf2009@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 426
Est. completion date December 2021
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• temozolomide

Radiation:
• prophylaxis cranial radiotherapy
2

Locations
Country Name City State
China The first affiliated hospital of Guangzhou MC Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 2-year incidence of brain metastases 2 year
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