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

Sponsor

Chonnam National University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01282151

Collaborator

Sanofi (Industry)

148

Enrollment

Locations

Arms

Duration (Months)

9.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Progression Free Survival [one year]
months after beginning of first cycle chemotherapy

Secondary Outcome Measures

Overall Survival (months from the beginning of first cycle chemotherapy) [three years]
months from the beginning of first cycle chemotherapy
Safety Profile [four months]
Toxicity using CTCAE version 4.0
Response rate [6-7th week]
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Chonnam National University Hwasun Hospital	Hwasun	Jeonnam	Korea, Republic of	519-709
2	Kyungpook National University Medical Center	Daegu	Kyungpook	Korea, Republic of
3	Hallym University Medical Center	Anyang		Korea, Republic of
4	Dankook University Hospital	Cheonan		Korea, Republic of	330-715
5	Keimyung University Dongsan Center	Daegu		Korea, Republic of	700-712
6	Yeungnam Univeristy Hospital	Daegu		Korea, Republic of
7	Chosun University Hospital	Gwangju		Korea, Republic of
8	Wonkwang University Hospital	Iksan		Korea, Republic of
9	Inha University Hospital	Incheon		Korea, Republic of
10	Pusan National University Hospital	Pusan		Korea, Republic of	602-739
11	Kosin University Gospel Hospital	Pusan		Korea, Republic of
12	Konkuk university medical center	Seoul		Korea, Republic of	143-729
13	Korea Cancer Center Hospital	Seoul		Korea, Republic of
14	Korea University Medical Center	Seoul		Korea, Republic of
15	Wonju Christian Hospital	Wonju		Korea, Republic of