Carcinoma, Non-Small-Cell LungPhase 2NCT01497041
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
A Phase 2 study testing Docetaxel and Oxaliplatin in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Squamous, run by Korean South West Oncology Group at 5 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous, Carcinoma, Large Cell
- What is being tested?
- Docetaxel and Oxaliplatin
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Feb 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
- Patients must be ≥ 18 years old of age
- ECOG performance status ≤ 1
- Estimated life expectancy of more than 3 months
- Treatment with only one prior chemotherapy
- At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
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- 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)
- Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
- Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)
- Provision of fully informed consent prior to any study specific procedures
Who cannot join
- Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
- Patients who received prior chemotherapy including paclitaxel or docetaxel
- 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)
- Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- 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
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan
Sang Byung Bae, M.D., +82-41-570-3667, baesan@schmc.ac.kr
Sang Byung Bae, M.D.
- Recruiting
Chungbuk National University Hospital
Cheongju-si
Ki Hyeong Lee, +82-43-269-6015, kihlee@chungbuk.ac.kr
Hye Suk Han
- Recruiting
Chungnam National University Hospital
Daejeon
Hwan Jung Yun, +82-42-280-7157, hjyun@cnuh.co.kr
Hwan Jung Yun
- Recruiting
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon
Suk Young Park, +82-42-220-9832, sypark1011@hotmail.com
Suk Young Park
- Recruiting
Chonbuk National University Hospital
Jeonju
Eun-Kee Song, +82-63-254-1609, eksong@jbnu.ac.kr
Eun-Kee Song
About this study
- 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
- 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
- Being tested
- Docetaxel, Oxaliplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Carcinoma, Large Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks
OxaliplatinDrug
Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Assessment of response will be assessed according to RECIST v1.1 criteria
Measured: 2years
Secondary outcomes (4)
Overall survival
Overall survival will be calculated by Kaplan-Meier method
Measured: 2years
Progression free survival
Progression free survival will be calculated by Kaplan-Meier method
Measured: 2 years
Number of Participants with Adverse Events
Assessment of toxicity will be assessed according to CTCAE version 4.0
Measured: 2 years
Quality of life
Quality of life will be assessed according to EORTC QLQ-C30, LC13
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean South West Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sang Byung Bae, M.D., Principal investigator, Soonchunhyang University Cheonan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497041
- Sponsor's protocol ID
- KSWOG 2010-3
- Status last verified
- Dec 2011
- First submitted
- 14 Dec 2011
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01497041
- Acronym / sponsor ID
- KSWOG 2010-3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Korean South West Oncology GroupResearch network
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
- Patients must be ≥ 18 years old of age
- ECOG performance status ≤ 1
- Estimated life expectancy of more than 3 months
- Treatment with only one prior chemotherapy
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
- Patients who received prior chemotherapy including paclitaxel or docetaxel
- 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)
- Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelDocetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks | Drug | – |
| OxaliplatinOxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks | Drug | – |
Primary outcome
Response rate
Time frame: 2years
Assessment of response will be assessed according to RECIST v1.1 criteria
4 secondary outcomes
Overall survival
Time frame: 2years
Progression free survival
Time frame: 2 years
Number of Participants with Adverse Events
Time frame: 2 years
Quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Byung Bae, M.D. principal investigator
Soonchunhyang University Cheonan Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Oxaliplatin in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Squamous, run by Korean South West Oncology Group at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Byung Bae (+82-41-570-3667, baesan@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2011.