Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02605811
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Guangzhou Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hailing Yang, MD
Principal Investigator Affiliation the first affiliated hospital of Guangzhou MC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Small Cell Lung Cancer, Metastatic Carcinoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: temozolomide

temozolomide oral 150mg/m2 d1-5/28d for 12 cycles

Active Comparator: prophylaxis cranial radiotherapy

prophylaxis cranial radiotherapy,25-30Gy/10Fra

Interventions

Drug: - temozolomide

Radiation: - prophylaxis cranial radiotherapy

2

Contact a Trial Team

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International Sites

Guangzhou, Guangdong, China

Status

Recruiting

Address

The first affiliated hospital of Guangzhou MC

Guangzhou, Guangdong, 510120

Site Contact

Haihong Yang, Dr.

bjrf2009@yahoo.com

0862083062825

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