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

NCT02972320 | Unknown Phase 2 DMC

• 1 other identifier: CLOG1601
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival (OS)

  3 years

• Tumor Response Rate (RR)

  3 months

• Treatment-related adverse events

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

Study Arms (1)

temozolomide maintain therapeutic

EXPERIMENTAL

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

Interventions

temozolomide DRUG

temozolomide maintain therapeutic

Also known as: Temozolomide Capsule

temozolomide maintain therapeutic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunpeng Liu: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

mingfang zhao, professor

CONTACT

13644055129; zhaomf618@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, clinical research

Study Record Dates

• First Submitted: October 23, 2016
• First Posted: November 23, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 23, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)