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TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer (TRAIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01282151
Recruitment Status : Terminated (Difficulty in recruitment due to approval of maintenance pemetrexed treatment)
First Posted : January 24, 2011
Last Update Posted : July 14, 2015
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non Small Cell Lung Drug: Taxotere Drug: Pemetrexed Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
Study Start Date : July 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Taxotere
Docetaxel plus Cisplatin
Drug: Taxotere
Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Other Names:
  • Taxotere(R)
  • Cisplatin

Active Comparator: Pemetrexed
Pemetrexed plus Cisplatin
Drug: Pemetrexed
Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Other Names:
  • Alimta (R)
  • Cisplatin

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: one year ]
    months after beginning of first cycle chemotherapy

Secondary Outcome Measures :
  1. Overall Survival (months from the beginning of first cycle chemotherapy) [ Time Frame: three years ]
    months from the beginning of first cycle chemotherapy

  2. Safety Profile [ Time Frame: four months ]
    Toxicity using CTCAE version 4.0

  3. Response rate [ Time Frame: 6-7th week ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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)
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01282151

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Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Jeonnam, Korea, Republic of, 519-709
Kyungpook National University Medical Center
Daegu, Kyungpook, Korea, Republic of
Hallym University Medical Center
Anyang, Korea, Republic of
Dankook University Hospital
Cheonan, Korea, Republic of, 330-715
Keimyung University Dongsan Center
Daegu, Korea, Republic of, 700-712
Yeungnam Univeristy Hospital
Daegu, Korea, Republic of
Chosun University Hospital
Gwangju, Korea, Republic of
Wonkwang University Hospital
Iksan, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of, 602-739
Kosin University Gospel Hospital
Pusan, Korea, Republic of
Konkuk university medical center
Seoul, Korea, Republic of, 143-729
Korea Cancer Center Hospital
Seoul, Korea, Republic of
Korea University Medical Center
Seoul, Korea, Republic of
Wonju Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Chonnam National University Hospital
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Study Chair: Young-Chul Kim, MD, PhD Chonnam National University Hospital
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Responsible Party: Young-Chul Kim, Professor, Chonnam National University Hospital Identifier: NCT01282151    
Other Study ID Numbers: DOCET_L_05478
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Keywords provided by Young-Chul Kim, Chonnam National University Hospital:
Non Squamous cell
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators