Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02972320
Other study ID # CLOG1601
Secondary ID
Status Recruiting
Phase Phase 2
First received October 23, 2016
Last updated November 22, 2016
Start date June 2016
Est. completion date December 2018

Study information

Verified date November 2016
Source China Medical University, China
Contact mingfang zhao, professor
Phone 13644055129
Email zhaomf618@126.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
temozolomide
temozolomide maintain therapeutic

Locations

Country Name City State
China The First Affiliated Hospital of China Medical University Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Yunpeng Liu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free Survival in the first line of chemotherapy The first day of treatment to the date that disease progression is reported 6 months No
Secondary Overall Survival (OS) The first day of treatment to death or last survival confirm date 3 years No
Secondary Tumor Response Rate (RR) The ratio between the number of responders and number of patients assessable for tumor response. 3 months No
Secondary 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 No
See also
  Status Clinical Trial Phase
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT01935336 - Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers Phase 2
Completed NCT00544596 - R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer Phase 1
Active, not recruiting NCT04063163 - A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Phase 3
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1
Completed NCT00773955 - R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer Phase 2
Completed NCT00528645 - AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer Phase 2
Recruiting NCT05468489 - To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC Phase 2
Active, not recruiting NCT00828139 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer Phase 2
Recruiting NCT05896059 - A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Anlotinib as Maintenance Therapy for ES-SCLC Phase 2
Recruiting NCT04346914 - Study of ZKAB001 Combined With Carboplatin and Etoposide in the Extensive Small Cell Lung Cancer Phase 1
Recruiting NCT06323265 - A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer
Withdrawn NCT01325753 - Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body N/A
Completed NCT00019006 - Vaccine Therapy in Treating Patients With Colon, Pancreatic, or Lung Cancer Phase 1
Not yet recruiting NCT04933175 - Fluzopalil in Combination With Anlotinib for Extensive Small-cell Lung Cancer Phase 2
Completed NCT01331525 - The Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT01155258 - Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors Phase 1
Terminated NCT00088933 - Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer Phase 1
Completed NCT00020202 - FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer Phase 2
Completed NCT02194049 - Cisplatin, Etoposide and PI3K Inhibitor BKM120 in Treating Patients With Advanced Solid Tumors or Small Cell Lung Cancer Phase 1