Extensive Stage Sclc Patients Who Were Benefit From First-line Treatment Accept Temozolomide Maintain Therapeutic

Yunpeng Liu

Status and phase: Unknown; Phase 2

Conditions: Extensive Stage Small Cell Lung Cancer

Treatments: Drug: temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02972320

CLOG1601

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged 18 to 70 years old, men and women are not limited;
2. confirmed by histopathological examination SCLC;
3. clinical stage for patients with extensive stage (except for the case of pleural effusion)
4. patients has no drug treatment history
5. the implementation of palliative radiotherapy for metastatic lesions, surgical treatment, after the end of treatment over 14 days.
6. there can be measured lesions (non radiation exposure site) of patients (RECIST) evaluation;
7. physical condition score ECOG PS:0-1
8. more than expected survival time over 3 months

Exclusion criteria

1. the previous platinum compounds have a history of allergies;
2. active ulcer patients;
3. Patients with primary lung lesions were treated with radiotherapy;
4. chest X-ray showed clear interstitial pneumonia or patients with pulmonary fibrosis;
5. the need for treatment of brain metastases in the active phase
6. there are more serious tumor invasion, superior vena cava syndrome, or in the middle volume of malignant pleural effusion, abdominal effusion or pericardial effusion, not yet control;
7. there is a serious infection, ADH abnormal secretion syndrome, poor control of diabetes,the need for the treatment of patients with severe complications such as vena cava syndrome

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

temozolomide maintain therapeutic

Experimental group

Description:

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.

Treatment:

Drug: temozolomide