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Metastatic Colorectal CancerPhase 3TAILORNCT01228734

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 Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients

A Phase 3 study testing Cetuximab, Oxaliplatin and Folinic Acid in people with Metastatic Colorectal Cancer, run by Merck KGaA, Darmstadt, Germany at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was 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 RAS wild-type tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Cetuximab, Oxaliplatin and Folinic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
553 participants
Where
25 sitesChina
Study dates
9 Sep 2010to 31 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent (first and second)
  • Chinese with Chinese citizenship
  • Male or female subjects greater than or equal to (>=) 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) RAS wild-type status in tumor tissue
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • 307 Hospital of PLA

    Beijing, 100071

  • The General Hospital of the People's Liberation Army

    Beijing, 100853

  • Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • First Affiliated Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Xiangya 2nd Hospital of Central South University

    Changsha, Hunan, 410011

  • Southwest Hospital

    Chongqing, 400038

  • Fujian Province Cancer Hospital

    Fuzhou, Fujian, 350014

  • Fuzhou General Hospital

    Fuzhou, Fujian, 350025

  • First Hospital Affiliated to Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510405

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310016

  • The Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150040

  • Yunnan Provincial Tumor Hospital

    KunMing, Yunnan, 650118

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, Shandong, 266003

  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai First People's Hospital

    Shanghai, 200080

  • Fudan University Zhongshan Hospital

    Shanghai

  • The First Affiliated Hospital of Soochow University

    Shuzhou, Jiangsu, 215006

  • Tianjin People's Hospital

    Tianjin, 30000

  • Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430023

  • Xijing Hospital the 4th Military Medical University of PLA

    Xi'an, 710032

Other trials in China

About this study

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 RAS Wild-type Status

The purpose of this study was 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 RAS wild-type tumors.

Being tested
Cetuximab, Oxaliplatin, Folinic Acid, 5Fluorouracil
Keywords
Metastatic colorectal cancer, RAS wild type, Cetuximab, First line treatment, First occurrence of metastatic colorectal cancer in Chinese subjects with RAS wildtype, status
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabDrug

    Also called Erbitux, C225

    Cetuximab was administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity to cetuximab.

  • OxaliplatinDrug

    Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.

  • Folinic AcidDrug

    FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.

  • 5FluorouracilDrug

    5-FU as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infusion over 22 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.

Study groups in NCT01228734
Study groupRoleWhat they receive
Cetuximab + FOLFOX-4ExperimentalSubjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab was always administered every 7 days with an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Receives: Drug: Cetuximab; Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5Fluorouracil
FOLFOX-4Active comparatorSubjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Time

    PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.

    Measured: Baseline up to 333 weeks

Secondary outcomes (4)

  1. Overall Survival (OS) Time

    OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.

    Measured: Baseline up to 333 weeks

  2. Best Overall Response Rate (ORR)

    The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.

    Measured: Baseline up to 333 weeks

  3. Time to Treatment Failure (TTF)

    TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator's assessment (if radiological confirmation of PD by IRC was unavailable), 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 or randomization. Subjects without event were censored on the date of last tumor assessment.

    Measured: Baseline up to 333 weeks

  4. Number of Subjects With Curative Surgery of Liver Metastases

    The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions.

    Measured: Baseline up to 333 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2010 (estimated)
  2. Study start9 Sep 2010
  3. Primary completion25 Jan 2016
  4. Study completion31 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
553 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01228734
Sponsor's protocol ID
EMR62202-057
Acronym
TAILOR
Status last verified
Jan 2020
First submitted
9 Sep 2010
Last updated
28 Jan 2020
Data monitoring committee
Yes

Publications

  • Wang H, Huang L, Gao P, Zhu Z, Ye W, Ding H, Fang L. Cost-effectiveness analysis of cetuximab combined with chemotherapy as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer based on the TAILOR trial. BMJ Open. 2020 Feb 12;10(2):e030738. doi: 10.1136/bmjopen-2019-030738.

    PubMed 32051297

  • Bai L, Zhang P, Zhou K, Liao W, Li Q. Cost-Effectiveness Analysis of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) versus FOLFOX-4 in Patients with RAS Wild-Type Metastatic Colorectal Cancer. Cancer Manag Res. 2019 Dec 12;11:10419-10426. doi: 10.2147/CMAR.S219318. eCollection 2019.

    PubMed 31849531

  • Qin S, Li J, Wang L, Xu J, Cheng Y, Bai Y, Li W, Xu N, Lin LZ, Wu Q, Li Y, Yang J, Pan H, Ouyang X, Qiu W, Wu K, Xiong J, Dai G, Liang H, Hu C, Zhang J, Tao M, Yao Q, Wang J, Chen J, Eggleton SP, Liu T. Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial. J Clin Oncol. 2018 Oct 20;36(30):3031-3039. doi: 10.1200/JCO.2018.78.3183. Epub 2018 Sep 10.

    PubMed 30199311

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cetuximab, Oxaliplatin and Folinic Acid in people with Metastatic Colorectal Cancer, run by Merck KGaA, Darmstadt, Germany at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Time (time frame: Baseline up to 333 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01228734, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.

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