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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001737
Receipt No. R000002052
Scientific Title Phase I/II study of docetaxel, CDDP and 5-FU therapy in patients with unresectable or recurrent esophageal cancer (JCOG 0807)
Date of disclosure of the study information 2009/02/27
Last modified on 2014/12/04

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Basic information
Public title Phase I/II study of docetaxel, CDDP and 5-FU therapy in patients with unresectable or recurrent esophageal cancer (JCOG 0807)
Acronym Phase I/II study of docetaxel, CDDP and 5-FU therapy in patients with unresectable or recurrent esophageal cancer (JCOG 0807)
Scientific Title Phase I/II study of docetaxel, CDDP and 5-FU therapy in patients with unresectable or recurrent esophageal cancer (JCOG 0807)
Scientific Title:Acronym Phase I/II study of docetaxel, CDDP and 5-FU therapy in patients with unresectable or recurrent esophageal cancer (JCOG 0807)
Region
Japan

Condition
Condition esophageal neoplasm
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I part: to evaluate maximum tolerated dose and dose-limiting toxicities to determine recommended dose of docetaxel in combination with a fixed dose of cisplatin and 5-FU in patients with unresectable or recurrent esophageal cancer.

Phase II part: to evaluate the efficacy and safery of combination chemotherapy with docetaxel, cisplatin and 5-FU in patients with unresectable or recurrent esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: Incidence of dose limiting toxicity
Phase II: Response rate
Key secondary outcomes Phase I: Adverse events, Response rate.
Phase II: Overall survival, Progression-free survival, Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Combination chemotherapy consists of docetaxel (30 or 40 mg/m2/day, day 1 and day 15), cisplatin (80 mg/m2/day, day 1), and 5-FU (800mg/m2/day, days 1 through 5). The treatment is repeated every 4 weeks until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
Interventions/Control_2
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) Lesion mainly located in the cervical or thoracic esophagus
2) Histologically proven squamous cell carcinoma, adenosquamous caricinoma , or adenocarcinoma
3) Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy
4) Aged 20 to 75 years old
5) ECOG Performance status 0 or 1
6) Measurable lesion
7) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancer
8) Adequate organ functions
9) Without symptomatic brain metastasis
10) Without moderate or more ascites/pleural effusion
11) Written informed consent
Key exclusion criteria 1) Uncontrollable diabetes mellitus or administration of insulin.
2) Simultaneous or metachronous (within 5 years) double cancers.
3) History of hypersensitivity to DOC, CDDP, 5-FU, or polysorbate 80
4) Active bacterial or fungous infection.
5) Systemic steroids medication
6) Motor paralysis or peripheral neuropathy by any reason
7) Edema by any reason
8) Interstitial pneumonia or fibroid lung
9) Psychosis
10) Pregnant or lactating women
Target sample size 64

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-Chou, Sunto-Gun, Shizuoka 411-8777, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Hironaka
Organization JCOG0807 Coordinating Office
Division name Division of Gastrointestinal Oncology
Zip code
Address 666-2, Nitonatyo, Chuo-ku,Chiba city ,Chiba Pref 260-8717, Japan.
TEL 043-264-5431
Homepage URL http://www.jcog.jp/
Email

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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(北海道)
岩手医科大学(岩手県)
東北大学病院(宮城県)
山形県立中央病院(山形県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
千葉県がんセンター(千葉県)
千葉大学医学部(千葉県)
総合病院国保旭中央病院(千葉県)
東京歯科大学市川総合病院(千葉県)
国立がんセンター中央病院(東京都)
東京女子医科大学(東京都)
国立病院機構東京医療センター(東京都)
慶應義塾大学病院(東京都)
昭和大学病院(東京都)
東京医科歯科大学(東京都)
癌研究会有明病院(東京都)
虎の門病院(東京都)
順天堂大学医学部(東京都)
東海大学医学部(神奈川県)
神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟大学医歯学総合病院(新潟県)
佐久総合病院(長野県)
静岡県立総合病院(静岡県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
京都大学医学部附属病院(京都府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪市立総合医療センター(大阪府)
大阪医科大学(大阪府)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
広島市立安佐市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
国立病院機構九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25041052
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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 Completed
Date of protocol fixation
2009 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 27 Day
Last modified on
2014 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002052

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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