History of Changes for Study: NCT01228734

A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type Patients (TAILOR)

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Study Record Versions

Version	Submitted Date	Changes
1	October 25, 2010	None (earliest Version on record)
2	December 22, 2010	Study Status and Contacts/Locations
3	February 22, 2011	Study Status, Contacts/Locations, Outcome Measures and Conditions
4	February 13, 2012	Contacts/Locations, Sponsor/Collaborators, Study Status and Conditions
5	December 20, 2012	Recruitment Status, Contacts/Locations, Study Status and Study Design
6	June 20, 2014	Study Status, Contacts/Locations, Outcome Measures, Study Identification, Eligibility, Study Design, Conditions and Study Description
7	June 26, 2015	Contacts/Locations, Study Status and Study Design
8	December 29, 2015	Study Status
9	May 23, 2016	Study Status
10	January 13, 2017	Arms and Interventions, Study Status, Outcome Measures, Results, Eligibility and Study Design
11	June 21, 2017	Study Status, Outcome Measures and Baseline Characteristics
12	October 10, 2017	Study Status
13	December 7, 2017	Study Status
14	May 28, 2018	Recruitment Status and Study Status
15	January 31, 2019	Adverse Events, Outcome Measures, Participant Flow, More Information, Arms and Interventions, Study Status and Study Description
16	January 16, 2020	Study Status and Outcome Measures

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	EMR62202-057
Brief Title:	A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type Patients (TAILOR)
Official Title:	An Open-label, Randomized, Controlled, Multicenter Phase III Trial to Compare Cetuximab in Combination With FOLFOX-4 Versus FOLFOX-4 Alone in the First Line Treatment of Metastatic Colorectal Cancer in Chinese Subjects With KRAS Wild-type Status
Secondary IDs:

Study Status


Record Verification:	October 2010
Overall Status:	Recruiting
Study Start:	September 2010
Primary Completion:	October 2013 [Anticipated]
Study Completion:

First Submitted:	September 9, 2010
First Submitted that Met QC Criteria:	October 25, 2010
First Posted:	October 26, 2010 [Estimate]

Last Update Submitted that Met QC Criteria:	October 25, 2010
Last Update Posted:	October 26, 2010 [Estimate]

Sponsor/Collaborators


Sponsor:	Merck KGaA, Darmstadt, Germany
Responsible Party:
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description


Brief Summary:	The purpose of this study is to assess whether the progression free survival (PFS) time with FOLFOX-4 plus cetuximab is longer than that with FOLFOX-4 alone as first-line treatment for mCRC in Chinese subjects with KRAS wild-type tumors.
Detailed Description:

Conditions


Conditions:	Metastatic Colorectal Cancer
Keywords:	Metastatic colorectal cancer KRAS wild type Cetuximab First line treatment First occurrence of metastatic colorectal cancer in Chinese subjects with KRAS wildtype status

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	360 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Cetuximab plus FOLFOX4

All eligible participants will receive the cetuximab in combination with FOLFOX4 regimen chemotherapy.

Drug: Cetuximab + Oxaliplatin + 5FU/FA

Cetuximab will always be administered first, followed by oxaliplatin (85mg/m2, infused over 120 minutes) at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-fluorouracil (5-FU) (as a bolus of 400 mg/m2/day IV over 2-4 minutes followed by 600 mg/m2/day infused over 22-hour, on day 1 and day 2, every two weeks). All subjects will receive treatment until the occurrence of progressive disease (PD) or unacceptable toxicity to cetuximab.

Other Names:

Erbitux
C225

FOLFOX4

All eligible participants will receive the FOLFOX4 regimen chemotherapy.

Drug: Oxaliplatin + 5FU/FA

Oxaliplatin (85mg/m2, infused over 120 minutes) will always be administered first or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m2/day IV over 2-4 minutes followed by 600 mg/m2/day infused over 22-hour, on day 1 and day 2, every two weeks). All subjects will receive treatment until the occurrence of progressive disease (PD) or unacceptable toxicity.

Outcome Measures


Primary Outcome Measures:
1.	Progression free survival (PFS) [ Time Frame: Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Sep 2010, until cut-off date expected Oct 2013 ] PFS is defined as duration from randomization until radiological progression (based on Response Evaluation Criteria In Solid Tumors (RECIST)) or death due to any cause. Only deaths within 90 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Secondary Outcome Measures:
1.	Overall survival time [ Time Frame: Time from randomization to death or last date known to be alive, reported between day of first patient randomised, Sep 2010, until cut-off date expected Oct 2013 ] Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
2.	Best overall response rate [ Time Frame: Evaluations were performed every 8 weeks until progression, reported between day of first patient randomised, Sep 2010, until cut-off date expected Oct 2013 ] The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified RECIST criteria).
3.	Time to treatment failure [ Time Frame: Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, Sep 2010, until cut-off date expected Oct 2013 ] Time to treatment failure is defined as time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 90 days of last tumor assessment). Patients without event are censored on the date of last tumor assessment.
4.	Rate of curative surgery for liver metastases [ Time Frame: Time from randomization until end of treatment, reported between day of first patient randomised, Sep 2010, until cut-off date expected Oct 2013 ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Signed written informed consent (first and second) Chinese with Chinese citizenship Male or female subjects ≥18 years of age Medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 90 days after the last dose of trial treatment) Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum First occurrence of metastatic disease (not curatively resectable) KRAS wild-type status in tumor tissue At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST (not in an irradiated area) Life expectancy of at least 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry White blood cell count ≥ 3 × 10x9/L with neutrophils ≥ 1.5 × 10x9/L, platelet count ≥ 100 × 10x9/L and hemoglobin ≥ 6.21 mmol/L (10 g/dL) Total bilirubin ≤ 1.5 × upper limit of reference range Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of reference range or ≤ 5 × upper reference range in subjects with liver metastasis Serum creatinine ≤ 1.5 × upper limit of reference range Recovery from relevant toxicity due to previous treatment before trial entry Exclusion Criteria: Previous chemotherapy for CRC except adjuvant treatment if terminated > 9 months (oxaliplatin-based chemotherapy) or > 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 30 days before trial treatment Previous treatment with monoclonal antibody therapy, vascular endothelial growth factor (VEGF) pathway-targeting therapy, epidermal growth factor receptor (EGFR) pathway-targeting therapy, or other signal transduction inhibitors History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation Renal replacement therapy Intake of any investigational medication within 30 days before trial entry Concurrent chronic systemic immune therapy or hormone therapy except physiologic replacement Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry (these growth factors may be used during the trial thereafter) Other non-permitted concomitant anticancer therapies Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease Active clinically serious infections (> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C Peripheral neuropathy > grade 1 Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure Known hypersensitivity or allergic reactions against any of the components of the trial treatments Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding Ongoing alcohol or drug abuse Presence of a medical or psychological condition that would not permit the subject to complete the trial or sign informed consent Participation in another clinical trial within the past 30 days Other significant disease that in the investigator's opinion should exclude the subject from the trial Legal incapacity or limited legal capacity

Contacts/Locations


Central Contact Person:	Merck KGaA Communication Center Telephone: 0049-6151-72520 Email: service@merck.de
Study Officials:	Angela Zubel, MD Study Director Merck Serono GCDU Oncology / China R&D Center
	Todd LI, MD Study Director R&D Center Merck Serono China
Locations:	China
	307 Hospital of PLA [Not yet recruiting] Beijing, China, 100071 Contact:Contact: Jianming XU 86 01-66947176 jmxu2003@yahoo.com Contact:Principal Investigator: Jianming XU
	The General Hospital of the People's Liberation Army [Not yet recruiting] Beijing, China, 100853 Contact:Contact: Fangfang JING 86 10 66937003 Jingfangfang8@163.com Contact:Principal Investigator: Guanghai DAI
	Affiliated Hospital of Bengbu Medical College [Not yet recruiting] Bengbu, China, 233004 Contact:Contact: ZHANG Jingjing 0086 13615528053 qiongwu68@yahoo.com.cn Contact:Principal Investigator: WU Qiong
	Southwest Hospital [Not yet recruiting] Chongqing, China, 4000388 Contact:Contact: Xiaoxin ZHAO (86) 23-68765704 zhaoxx2025@yahoo.cn Contact:Principal Investigator: Houjie LIANG
	The Tumor Hospital of Harbin Medical University [Not yet recruiting] Harbin, China, 150040 Contact:Contact: Xiaoli WEI 86 451 86298265 weixiaoli2008@sohu.com Contact:Principal Investigator: Yuxian BAI
	The Affiliated Hospital of Medical College Qingdao University [Not yet recruiting] Qingdao, China, 266003 Contact:Contact: QUI Wensheng 0086 13370698518 Liangjun1959@yahoo.com.cn Contact:Principal Investigator: LIANG Jun
	Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine [Not yet recruiting] Shanghai, China, 200025 Contact:Contact: LIU Ying 0086 21 64370045 jun_zj10977@yahoo.com.cn Contact:Principal Investigator: ZHANG Jun
	Fudan University Shanghai Cancer Center [Not yet recruiting] Shanghai, China, 200032 Contact:Contact: Weijian GUO 86 21 64433755 fudanlijin@163.com Contact:Principal Investigator: Jin LI
	Shanghai First People's Hospital [Not yet recruiting] Shanghai, China, 200080 Contact:Contact: Haiyan YANG 86 21 63240090 briannayang@gmail.com Contact:Principal Investigator: Liwai WANG
	China, Fujan
	Fuzhou General Hospital [Not yet recruiting] Fuzhou, Fujan, China, 350025 Contact:Contact: Shuyi CHEN (86) 591-22859750 xiaoyi307@126.com Contact:Principal Investigator: Xuenong OUYANG
	China, Fujian
	Fujian Province Cancer Hospital [Not yet recruiting] Fuzhou, Fujian, China, 350014 Contact:Contact: Wei GAO 86 13960986882 gaowei@medmail.com.cn Contact:Principal Investigator: Jianwei YANG
	China, Guangdong
	First Hospital Affiliated to Guangzhou University of Chinese Medicine [Recruiting] Guangzhou, Guangdong, China, 510405 Contact:Contact: Xinting ZHENG 86-20-36596380 zxt710@yahoo.com.cn Contact:Principal Investigator: Lizhu LIN
	Nanfang Hospital of Southern Medical University [Not yet recruiting] Guangzhou, Guangdong, China, 510515 Contact:Contact: Jinzhang CHEN 86 0 13902251269 chenjinzhang@hotmail.com Contact:Principal Investigator: Rongchang LUO
	China, Hubei
	Union Hospital of Tongji Medical College of Huazhong University of Science and Technology [Not yet recruiting] Wuhan, Hubei, China, 430023 Contact:Contact: Tao ZHANG 86-27-65650733 taozhangwh@yahoo.com.cn Contact:Principal Investigator: Gang WU
	China, Jilin
	Jilin Cancer Hospital [Recruiting] Changchun, Jilin, China, 130012 Contact:Contact: Juying XING 86-431-85536383 xjy730202@hotmail.com Contact:Principal Investigator: Ying CHENG
	China, Zhejiang
	The First Affiliated Hospital of College of Medicine, Zhejiang University [Not yet recruiting] Hangzhou, Zhejiang, China, 310009 Contact:Contact: Nong XU (+86)13515715262 xunonghz@163.com Contact:Principal Investigator: Nong XU
	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University [Not yet recruiting] Hangzhou, Zhejiang, China, 310016 Contact:Contact: Hongming PAN (86) 13605716662 panhongming@tom.com Contact:Principal Investigator: Hongming PAN

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