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A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Korean South West Oncology Group.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Korean South West Oncology Group Identifier:
First received: December 14, 2011
Last updated: December 19, 2011
Last verified: December 2011
  1. Goals

    The primary goal of this phase II trial is to:

    evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment

    Secondary goals are to:

    evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population

  2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous
Carcinoma, Large Cell
Drug: Docetaxel
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment

Resource links provided by NLM:

Further study details as provided by Korean South West Oncology Group:

Primary Outcome Measures:
  • Response rate [ Time Frame: 2years ]
    Assessment of response will be assessed according to RECIST v1.1 criteria

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2years ]
    Overall survival will be calculated by Kaplan-Meier method

  • Progression free survival [ Time Frame: 2 years ]
    Progression free survival will be calculated by Kaplan-Meier method

  • Number of Participants with Adverse Events [ Time Frame: 2 years ]
    Assessment of toxicity will be assessed according to CTCAE version 4.0

  • Quality of life [ Time Frame: 2 years ]
    Quality of life will be assessed according to EORTC QLQ-C30, LC13

Estimated Enrollment: 35
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel
    Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks
    Drug: Oxaliplatin
    Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
  2. Patients must be ≥ 18 years old of age
  3. ECOG performance status ≤ 1
  4. Estimated life expectancy of more than 3 months
  5. Treatment with only one prior chemotherapy
  6. At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  7. Adequate bone marrow function (absolute neutrophil count [ANC] ≥ 1,500/µL, hemoglobin ≥ 9.0 g/dL [correction by transfusion is acceptable], and platelets ≥ 100,000/µL)
  8. Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
  9. Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)
  10. Provision of fully informed consent prior to any study specific procedures

Exclusion Criteria:

  1. Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
  2. Patients who received prior chemotherapy including paclitaxel or docetaxel
  3. Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
  4. Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
  5. Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
  6. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01497041

Contact: Sang Byung Bae +82-41-570-3667
Contact: Hwan Jung Yun +82-42-280-7157

Korea, Republic of
Soonchunhyang University Cheonan Hospital Recruiting
Cheonan, Korea, Republic of
Contact: Sang Byung Bae, M.D.    +82-41-570-3667   
Principal Investigator: Sang Byung Bae, M.D.         
Sub-Investigator: Han Jo Kim, M.D.         
Sub-Investigator: Kyu Taek Lee, M.D.         
Chungbuk National University Hospital Recruiting
Cheongju, Korea, Republic of
Contact: Ki Hyeong Lee    +82-43-269-6015   
Sub-Investigator: Hye Suk Han         
Principal Investigator: Ki Hyeong Lee         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Hwan Jung Yun    +82-42-280-7157   
Principal Investigator: Hwan Jung Yun         
Sub-Investigator: Sam Yong Kim         
Sub-Investigator: Hyo Jin Lee         
The Catholic University of Korea Daejeon ST. Mary's Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Suk Young Park    +82-42-220-9832   
Principal Investigator: Suk Young Park         
Sub-Investigator: Young Joon Yang         
Sub-Investigator: Ji Chan Park         
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Eun-Kee Song    +82-63-254-1609   
Principal Investigator: Eun-Kee Song         
Sub-Investigator: Chang-Yeol Yim         
Sub-Investigator: Na-Ri Lee         
Sponsors and Collaborators
Korean South West Oncology Group
Principal Investigator: Sang Byung Bae, M.D. Soonchunhyang University Cheonan Hospital
  More Information

Responsible Party: Korean South West Oncology Group Identifier: NCT01497041     History of Changes
Other Study ID Numbers: KSWOG 2010-3
Study First Received: December 14, 2011
Last Updated: December 19, 2011

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Carcinoma, Large Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017