Carcinoma, Non Small Cell LungPhase 3TRAILNCT01282151
TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
A Phase 3 study testing Taxotere and Pemetrexed in people with Carcinoma, Non Small Cell Lung, run by Chonnam National University Hospital at 15 sites in South Korea.
Trial summary
This study is: A multicenter, prospective, randomized, phase 3 trial. To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer. 276 patients will be recruited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non Small Cell Lung
- What is being tested?
- Taxotere and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 15 sitesSouth Korea
- Study dates
- Jul 2011to Dec 2014
- Phase
- Phase 3
- 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
- Age >= 18 years old
- ECOG performance status 0-2
- Non-squamous cell type non-small cell lung cancer (NSCLC)
- Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy
- No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.
- No prior immunotherapy, biologic therapy
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- Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Hemoglobin >=9.0g/dl, Platelet >=100,000/uL, neutrophil >=1,500 /uL Creatinine <=1.5 x upper normal limit or creatinine clearance >=60 mL/min Bilirubin <=1.5 x upper normal limit, Transaminases <=2 x upper normal limit Alkaline phosphatase <=2 x upper normal limit
- Written informed consent
Who cannot join
- Pregnancy, Lactating woman
- Woman in child bearing age who refuses to do pregnancy test
- Moderate or greater than grade 1 motor or sensory neurotoxicity
- Hypersensitivity to taxane
- Comorbidity or poor medical conditions
- Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)
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- Concurrent treatment with other investigational drugs within 30 days before randomization
- Active treatment with other anticancer chemotherapy
- EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Hallym University Medical Center
Anyang
Dankook University Hospital
Cheonan, 330-715
Kyungpook National University Medical Center
Daegu, Kyungpook
Keimyung University Dongsan Center
Daegu, 700-712
Yeungnam Univeristy Hospital
Daegu
Chosun University Hospital
Gwangju
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 519-709
Wonkwang University Hospital
Iksan
Inha University Hospital
Incheon
Pusan National University Hospital
Pusan, 602-739
Kosin University Gospel Hospital
Pusan
Konkuk university medical center
Seoul, 143-729
Korea Cancer Center Hospital
Seoul
Korea University Medical Center
Seoul
Wonju Christian Hospital
Wŏnju
About this study
Official title: A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
This study is:
- A multicenter, prospective, randomized, phase 3 trial.
- To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer.
- 276 patients will be recruited.
Read the detailed description
Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.
- Conditions
- Carcinoma, Non Small Cell Lung
- Being tested
- Taxotere, Pemetrexed
- Keywords
- NSCLC, Non Squamous cell, Docetaxel, Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxotereDrug
Also called Taxotere(R), Cisplatin
Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
PemetrexedDrug
Also called Alimta (R), Cisplatin
Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Taxotere | Experimental | Docetaxel plus Cisplatin Receives: Drug: Taxotere |
| Pemetrexed | Active comparator | Pemetrexed plus Cisplatin Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
months after beginning of first cycle chemotherapy
Measured: one year
Secondary outcomes (3)
Overall Survival (months from the beginning of first cycle chemotherapy)
months from the beginning of first cycle chemotherapy
Measured: three years
Safety Profile
Toxicity using CTCAE version 4.0
Measured: four months
Response rate
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 6-7th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2014
Why it stopped: Difficulty in recruitment due to approval of maintenance pemetrexed treatment
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Young-Chul Kim, Chonnam National University Hospital
- Investigators
- Young-Chul Kim, MD, PhD, Study chair, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282151
- Sponsor's protocol ID
- DOCET_L_05478
- Acronym
- TRAIL
- Status last verified
- Jul 2015
- First submitted
- 21 Jan 2011
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
- ClinicalTrials.gov ID
- NCT01282151
- Acronym / sponsor ID
- TRAIL / DOCET_L_05478
- Conditions
- Carcinoma, Non Small Cell Lung
- Keywords
- NSCLC, Non Squamous cell, Docetaxel, Pemetrexed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment due to approval of maintenance pemetrexed treatment
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Jan 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.
This study is:
- A multicenter, prospective, randomized, phase 3 trial.
- To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer.
- 276 patients will be recruited.
Detailed description
Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxotere | Experimental | Drug: TaxotereDocetaxel plus Cisplatin |
| Pemetrexed | Active comparator | Drug: PemetrexedPemetrexed plus Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >= 18 years old
- ECOG performance status 0-2
- Non-squamous cell type non-small cell lung cancer (NSCLC)
- Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy
- No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.
Key exclusion criteria (9 listed)
- Pregnancy, Lactating woman
- Woman in child bearing age who refuses to do pregnancy test
- Moderate or greater than grade 1 motor or sensory neurotoxicity
- Hypersensitivity to taxane
- Comorbidity or poor medical conditions
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 |
|---|---|---|
| TaxotereAlso: Taxotere(R), CisplatinDocetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks | Drug | Taxotere |
| PemetrexedAlso: Alimta (R), CisplatinPemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks | Drug | Pemetrexed |
Primary outcome
Progression Free Survival
Time frame: one year
months after beginning of first cycle chemotherapy
3 secondary outcomes
Overall Survival (months from the beginning of first cycle chemotherapy)
Time frame: three years
Safety Profile
Time frame: four months
Response rate
Time frame: 6-7th week
Results and safety
The study was stopped early (reason given: Difficulty in recruitment due to approval of maintenance pemetrexed treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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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.
Young-Chul Kim, MD, PhD study chair
Chonnam National University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Taxotere and Pemetrexed in people with Carcinoma, Non Small Cell Lung, run by Chonnam National University Hospital at 15 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruitment due to approval of maintenance pemetrexed treatment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: one year). 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 14 Jul 2015.