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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015107
Receipt No. R000017550
Scientific Title A randomized controlled phase III study comparing docetaxel, cisplatin and 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)
Date of disclosure of the study information 2014/09/10
Last modified on 2016/05/20

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Basic information
Public title A randomized controlled phase III study comparing docetaxel, cisplatin and 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)
Acronym A randomized phase III study comparing 2-weekly docetaxel combined with cisplatin plus 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)
Scientific Title A randomized controlled phase III study comparing docetaxel, cisplatin and 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)
Scientific Title:Acronym A randomized phase III study comparing 2-weekly docetaxel combined with cisplatin plus 5-FU (2-weekly DCF) with cisplatin and 5-FU (CF) in patients with metastatic or recurrent esophageal cancer (JCOG1314, MIRACLE study)
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the superiority of 2-weekly DCF to CF in terms of OS for patients with metastatic or recurrent esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression-free survival, response rate, proportion of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Receiving cisplatin (80 mg/m2, 2-h intravenous infusion on day 1) and fluorouracil (800 mg/m2, 24-h continuous intravenous infusion on days 1-5), repeated every 4 weeks
Interventions/Control_2 B: Receiving docetaxel (30 mg/m2, 1-h intravenous infusion on day 1 and 15), cisplatin (80 mg/m2, 2-h intravenous infusion on day 1) and fluorouracil (800 mg/m2, 24-h continuous intravenous infusion day on days 1-5), repeated every 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Primary tumor located at cervical esophagus, thoracic esophagus or esophago-gastric junction
2)Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or basaloid carcinoma (Siewert type II/III adenosquamous carcinoma or adenocarcinoma is ineligible.)
3)Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy
A)In case of unresectable esophageal cancer, all of the following conditions must be fulfilled:
i)Having metastatic lesion except for #102 or #104 metastases
ii)cT1-cT4a
iii)Dysphagia score =<2 and no stenosis which endoscope does not pass through
B)In case of recurrent esophageal cancer, all of the following conditions must be fulfilled:
i)Having metastatic lesion except for #102 or #104 metastases
ii)Dysphagia score =<2
4)Aged 20 to 75 years old
5)ECOG PS of 0 or 1
6)No symptomatic bone or brain metastases
7) No massive ascites/pleural effusion
8)Measurable lesions not required
9)As for previous therapy, either A) or B) must be fulfilled:
A)When preoperative chemotherapy or postoperative chemotherapy was given as previous therapy, meet all of the following 4 factors:
i)Recurrence was detected more than 24 weeks after previous therapy was completed
ii)Previous therapy was not terminated due to adverse events, patient refusal
iii)Tumor response by previous therapy was not judged as disease progression
iv)Total dose of prior CDDP =< 210 mg/m2
B)When preoperative chemoradiotherapy, concurrent chemoradiotherapy or radiotherapy alone were received as previous therapy, meet all of the following 5 factors:
i)More than 52 weeks after radiotherapy when lung was involved in radiation field
ii)No history of grade 2-4 pneumonitis
iii)Previous therapy was not terminated due to adverse events, patient refusal
iv)Tumor response by previous therapy was not judged as disease progression
v)Total dose of prior CDDP =< 210 mg/m2
10)Sufficient organ function
11)Written informed consent
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Active infection requiring systemic therapy.
3) Pregnancy, possible pregnancy or breastfeeding.
4) Psychiatric disease.
5) Patients requiring systemic steroid medication.
6) Under treatment with flucytosine, phenytoin, or warfarin.
7) History of iodine allergy.
8) History of hypersensitivity to DOC, CDDP, or polysorbate 80.
9) Poorly controlled diabetes mellitus.
10) Severe pulmonary fibrosis or emphysema.
11) Poorly controlled hypertension.
12) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
13) Positive HBs antigen, or positive HIV antibody
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Tsubosa
Organization Shizuoka Cancer Center
Division name Division of esophageal surgery
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222(81-55-989-5222)
Email y.tsubosa@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Hironaka
Organization JCOG1314 Coordinating Office
Division name Clinical Trial Promotion Department, Chiba Cancer Center
Zip code
Address 666-2 Nitona-cho Chuo-ku Chiba-shi, Chiba 260-8717, Japan
TEL 043-264-5431(81-43-264-5431)
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院
岩手医科大学
東北大学病院
栃木県立がんセンター
埼玉県立がんセンター
国立がん研究センター東病院
千葉県がんセンター
千葉大学医学部
東京歯科大学市川総合病院
国立がん研究センター中央病院
東京女子医科大学
国立病院機構東京医療センター
慶應義塾大学病院
昭和大学病院
がん研究会有明病院
新潟県立がんセンター新潟病院
佐久総合病院佐久医療センター
静岡県立総合病院
静岡県立静岡がんセンター
愛知県がんセンター中央病院
京都大学医学部附属病院
大阪府立病院機構大阪府立成人病センター
国立病院機構大阪医療センター
大阪市立総合医療センター
大阪医科大学
神戸大学医学部
関西労災病院
兵庫県立がんセンター
広島大学病院
広島市立安佐市民病院
国立病院機構四国がんセンター
高知医療センター
国立病院機構九州がんセンター
九州大学病院
熊本大学医学部
鹿児島大学医学部・歯学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
2020 Year 09 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 10 Day
Last modified on
2016 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017550

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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