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

NCT ID: NCT02972320

Last Updated: 2016-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-12-31

Brief Summary

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.

Detailed 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.

Conditions

Extensive Stage Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

temozolomide maintain therapeutic

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.

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

temozolomide maintain therapeutic

Interventions

temozolomide

temozolomide maintain therapeutic

Intervention Type: DRUG

Other Intervention Names

Temozolomide Capsule

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yunpeng Liu

OTHER

Sponsor Role: lead

Responsible Party

Yunpeng Liu

Director, clinical research

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

mingfang zhao, professor

Role: CONTACT

Phone: 13644055129

Email: zhaomf618@126.com

Facility Contacts

mingfang zhao, professor

Role: primary

Other Identifiers

CLOG1601

Identifier Type: -

Identifier Source: org_study_id