TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer (TRAIL)
This study is currently recruiting participants.
Verified January 2013 by Chonnam National University Hospital
Sponsor:
Chonnam National University Hospital
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
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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:
|
|
Active Comparator: Pemetrexed
Pemetrexed plus Cisplatin
|
Drug: Pemetrexed
Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Other Names:
|
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
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 Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Docetaxel Pemetrexed Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 22, 2013