UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001737 |
|---|---|
| Receipt number | 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 17:51:51 |
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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
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/
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002052
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| Registered date | File name |
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