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

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

temozolomide

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

the previous platinum compounds have a history of allergies;
active ulcer patients;
Patients with primary lung lesions were treated with radiotherapy;
chest X-ray showed clear interstitial pneumonia or patients with pulmonary fibrosis;
the need for treatment of brain metastases in the active phase
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;
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

Sites / Locations

The First Affiliated Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

temozolomide maintain therapeutic

Arm 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.

Outcomes

Primary Outcome Measures

Progression-Free Survival in the first line of chemotherapy

The first day of treatment to the date that disease progression is reported

Secondary Outcome Measures

Overall Survival (OS)

The first day of treatment to death or last survival confirm date

Tumor Response Rate (RR)

The ratio between the number of responders and number of patients assessable for tumor response.

Treatment-related adverse events

Treatment-related adverse events are assessed by common terminology criteria for adverse events (CTCAE) V4.0.

Full Information

NCT ID

NCT02972320

First Posted

October 23, 2016

Last Updated

November 22, 2016

Sponsor

Yunpeng Liu

1. Study Identification

Unique Protocol Identification Number

NCT02972320

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yunpeng Liu

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extensive Stage Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

temozolomide maintain therapeutic

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

temozolomide

Other Intervention Name(s)

Temozolomide Capsule

Intervention Description

temozolomide maintain therapeutic

Primary Outcome Measure Information:

Title

Progression-Free Survival in the first line of chemotherapy

Description

The first day of treatment to the date that disease progression is reported

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

The first day of treatment to death or last survival confirm date

Time Frame

3 years

Title

Tumor Response Rate (RR)

Description

The ratio between the number of responders and number of patients assessable for tumor response.

Time Frame

3 months

Title

Treatment-related adverse events

Description

Treatment-related adverse events are assessed by common terminology criteria for adverse events (CTCAE) V4.0.

Time Frame

the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: aged 18 to 70 years old, men and women are not limited; confirmed by histopathological examination SCLC; clinical stage for patients with extensive stage (except for the case of pleural effusion) patients has no drug treatment history the implementation of palliative radiotherapy for metastatic lesions, surgical treatment, after the end of treatment over 14 days. there can be measured lesions (non radiation exposure site) of patients (RECIST) evaluation; physical condition score ECOG PS:0-1 more than expected survival time over 3 months Exclusion Criteria: the previous platinum compounds have a history of allergies; active ulcer patients; Patients with primary lung lesions were treated with radiotherapy; chest X-ray showed clear interstitial pneumonia or patients with pulmonary fibrosis; the need for treatment of brain metastases in the active phase 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; 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

mingfang zhao, professor

Phone

13644055129

zhaomf618@126.com

Facility Information:

Facility Name

The First Affiliated Hospital of China Medical University

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

mingfang zhao, professor

Phone

13644055129

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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