UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015107
Receipt number 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 15:12:40

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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 or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



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

Value
https://center6.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