UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuhiro Tsubosa
Organization	Shizuoka Cancer Center
Division name	Division of esophageal surgery
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	Shuichi Hironaka
Organization	JCOG1314 Coordinating Office
Division name	Clinical Trial Promotion Department, Chiba Cancer Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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