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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chonnam National University Hospital
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01282151
First received: January 21, 2011
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Carcinoma, Non Small Cell Lung
Drug: Taxotere
Drug: Pemetrexed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: one year ] [ Designated as safety issue: No ]
    months after beginning of first cycle chemotherapy


Secondary Outcome Measures:
  • Overall Survival (months from the beginning of first cycle chemotherapy) [ Time Frame: three years ] [ Designated as safety issue: No ]
    months from the beginning of first cycle chemotherapy

  • Safety Profile [ Time Frame: four months ] [ Designated as safety issue: Yes ]
    Toxicity using CTCAE version 4.0

  • Response rate [ Time Frame: 6-7th week ] [ Designated as safety issue: No ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1


Estimated Enrollment: 276
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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 ClinicalTrials.gov identifier: NCT01282151

Contacts
Contact: Young-Chul Kim, MD, PhD 82-61-379-7614 kyc0923@jnu.ac.kr
Contact: In-Jae Oh, MD, PhD 82-61-379-7617 droij@jnu.ac.kr

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeonnam, Korea, Republic of, 519-709
Contact: Young-Chul Kim, MD, PhD    82-61-379-7614    kyc0923@jnu.ac.kr   
Contact: Sang-Hwa Park, BS    82-61-379-7616    pshhwa@nate.com   
Principal Investigator: Young-Chul Kim, MD, PhD         
Sub-Investigator: In-Jae Oh, MD, PhD         
Sub-Investigator: Hee-Jung Ban, MD         
Kyungpook National University Medical Center Recruiting
Daegu, Kyungpook, Korea, Republic of
Contact: Seung Soo Yoo, MD, PhD    82-10-9133-0641    007md@hanmail.net   
Principal Investigator: Seung Soo Yoo, MD, PhD         
Hallym University Medical Center Recruiting
Anyang, Korea, Republic of
Contact: Seung-Hun Jang, MD, PhD       chestor@hallym.or.kr   
Principal Investigator: Seung-Hun Jang, MD, PhD         
Dankook University Hospital Recruiting
Cheonan, Korea, Republic of, 330-715
Contact: YS Kim, MD, PhD       drys99@yahoo.co.kr   
Principal Investigator: YS Kim, MD, PhD         
Keimyung University Dongsan Center Recruiting
Daegu, Korea, Republic of, 700-712
Contact: CY Jung, MD       jcy2475@dsmc.or.kr   
Principal Investigator: CY Jung, MD         
Sub-Investigator: YJ Jeon, MD, PhD         
Yeungnam Univeristy Hospital Recruiting
Daegu, Korea, Republic of
Contact: Kwan-Ho Lee, MD, PhD       ghlee@med.yu.ac.kr   
Principal Investigator: Kwan-Ho Lee, MD, PhD         
Sub-Investigator: KC Shin, MD, PhD         
Chosun University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Sung-Ho Yoon, MD, PhD       drdbs@chosun.ac.kr   
Principal Investigator: Sung-Ho Yoon, MD, PhD         
Wonkwang University Hospital Recruiting
Iksan, Korea, Republic of
Contact: Sei-Hoon Yang, MD, PhD       yshpul@wonkwang.ac.kr   
Principal Investigator: Sei-Hoon Yang, MD, PhD         
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Contact: Jeong-Seon Ryu, MD, PhD       jsryu@inha.ac.kr   
Principal Investigator: Jeong-Seon Ryu, MD, PhD         
Kosin University Gospel Hospital Recruiting
Pusan, Korea, Republic of
Contact: Tae-Won Jang, MD, PhD       jangtw@ns.kosinmed.or.kr   
Principal Investigator: Tae-Won Jang, MD, PhD         
Sub-Investigator: Maan-Hong Jung, MD, PhD         
Sub-Investigator: Chulho Oak, MD, PhD         
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of, 602-739
Contact: Min-Ki Lee, MD, PhD       leemk@pusan.ac.kr   
Principal Investigator: Min-Ki Lee, MD, PhD         
Korea Cancer Center Hospital Recruiting
Seoul, Korea, Republic of
Contact: Cheol-Hyeon Kim, MD, PhD       cheol@kcch.re.kr   
Principal Investigator: Cheol-Hyeon Kim, MD, PhD         
Korea University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kwang-Ho In, MD, PhD       khin@kumc.or.kr   
Principal Investigator: Kwang-Ho In, MD, PhD         
Konkuk university medical center Recruiting
Seoul, Korea, Republic of, 143-729
Contact: Kye-Young Lee, MD, PhD       kyleemd@kuh.ac.kr   
Principal Investigator: Kye-Young Lee, MD, PhD         
Wonju Christian Hospital Recruiting
Wonju, Korea, Republic of
Contact: SJ Yong, MD, PhD       sjyong@yonsei.ac.kr   
Principal Investigator: SJ Yong, MD, PhD         
Sponsors and Collaborators
Chonnam National University Hospital
Sanofi
Investigators
Study Chair: Young-Chul Kim, MD, PhD Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: Young-Chul Kim, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01282151     History of Changes
Other Study ID Numbers: DOCET_L_05478
Study First Received: January 21, 2011
Last Updated: January 30, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonnam National University Hospital:
NSCLC
Non Squamous cell
Docetaxel
Pemetrexed

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 22, 2014