Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive stage SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the first line treatment.
According to the etoposide combined Los platinum (EL) plan administration, every cycle was 21 days, a total of four cycle. The patients who was clinical benefit directly from EL scheme in the first line treatment accept temozolomide maintenance therapy, 150mg / m2, oral D1-5. A period of 28 days, regular follow-up and evaluation of effectiveness, safety and quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| temozolomide maintain therapeutic | Experimental | Lobaplatin combined with etoposide for first-line treatment of extensive stage small cell lung cancer,then clinical benefit patients for temozolomide maintain therapeutic.This study have only one arm which temozolomide maintain at dose of 150mg/m2 D1-5 Q4W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug | temozolomide maintain therapeutic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival in the first line of chemotherapy | The first day of treatment to the date that disease progression is reported | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The first day of treatment to death or last survival confirm date | 3 years |
| Tumor Response Rate (RR) | The ratio between the number of responders and number of patients assessable for tumor response. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mingfang zhao, professor | Contact | 13644055129 | zhaomf618@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| Treatment-related adverse events | Treatment-related adverse events are assessed by common terminology criteria for adverse events (CTCAE) V4.0. | the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |