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

Phase 2

• Conditions: Extensive Stage Small Cell Lung Cancer
• Interventions: Drug: temozolomide

• Registration Number: NCT02972320
• Lead Sponsor: Yunpeng Liu

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-23
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-22
• Last Update Submitted: 2016-11-22
• Study First Posted: 2016-11-23
• Last Update Posted: 2016-11-23
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
temozolomide maintain therapeutic	temozolomide	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival in the first line of chemotherapy	6 months	The first day of treatment to the date that disease progression is reported

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	3 years	The first day of treatment to death or last survival confirm date
Tumor Response Rate (RR)	3 months	The ratio between the number of responders and number of patients assessable for tumor response.
Treatment-related adverse events	the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months	Treatment-related adverse events are assessed by common terminology criteria for adverse events (CTCAE) V4.0.

Trial Locations

Locations (1)

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China