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

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

Lobaplatin Combined With Etoposide for First-line Treatment in Extensive Stage Sclc Then Benefit Patients Follow up Temozolomide Maintain Therapeutic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02972320
• Other study ID #: CLOG1601
• Status: Recruiting
• Phase: Phase 2
• First received: October 23, 2016
• Last updated: November 22, 2016
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: China Medical University, China
• Contact: mingfang zhao, professor
• Phone: 13644055129
• Email: zhaomf618[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• temozolomide
temozolomide maintain therapeutic

Locations

Country	Name	City	State
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Yunpeng Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival in the first line of chemotherapy	The first day of treatment to the date that disease progression is reported	6 months	No
Secondary	Overall Survival (OS)	The first day of treatment to death or last survival confirm date	3 years	No
Secondary	Tumor Response Rate (RR)	The ratio between the number of responders and number of patients assessable for tumor response.	3 months	No
Secondary	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	No