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

• Sponsor: Yunpeng Liu (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02972320
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 30
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Extensive Stage Small Cell Lung Cancer	Drug: temozolomide	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lobaplatin Combined With Etoposide for First-line Treatment in Extensive Stage Sclc Then Benefit Patients Follow up Temozolomide Maintain Therapeutic
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Overall Survival (OS) [3 years]

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

2. Tumor Response Rate (RR) [3 months]

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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China	110001

Sponsors and Collaborators

• Yunpeng Liu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yunpeng Liu, Director, clinical research, China Medical University, China
• ClinicalTrials.gov Identifier: NCT02972320
• Other Study ID Numbers: CLOG1601
• First Posted: Nov 23, 2016
• Last Update Posted: Nov 23, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Small Cell Lung Carcinoma; Temozolomide

Study Results

No Results Posted as of Nov 23, 2016