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

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

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.

Study Overview

• Status: Unknown
• Conditions: Extensive Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: temozolomide

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: mingfang zhao, professor; Phone Number: 13644055129; Email: zhaomf618@126.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • The First Affiliated Hospital of China Medical University
      • Contact: mingfang zhao, professor; Phone Number: 13644055129

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: temozolomide; temozolomide maintain therapeutic; Other Names: Temozolomide Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Yunpeng Liu

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 23, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: CLOG1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No