UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000861 |
|---|---|
| Receipt number | R000001025 |
| Scientific Title | A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303) |
| Date of disclosure of the study information | 2007/10/23 |
| Last modified on | 2017/11/08 18:05:11 |
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Basic information
Public title
A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)
Acronym
A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)
Scientific Title
A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)
Scientific Title:Acronym
A Randomized PhaseII/III Study of Concurrent Chemoradiotherapy with Low Dose Cisplatin plus 5-FU versus Concurrent Chemoraiotherapy with Standard Dose Cisplatin plus 5-FU for Locally Advanced Unresetable Esophageal Cancer in the Thorax.(JCOG0303)
Region
| Japan |
Condition
Condition
Locally advanced unresectable esophageal cancer in the thorax
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safty of concurrent chemoradiotherapy of low dose cisplatin plus 5-FU compared with concurrent chemoradiotherapy of standard dose cisplatin plus 5-FU for locally advanced unresectable thoracic esophageal cancer without distant metastasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
overall survival
Key secondary outcomes
complete response rate, treatment completion rate, treatment completion rate by PS, 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 | Maneuver |
Interventions/Control_1
A: Standard Dose concurrent chemoradiotherapy (RT: 60Gy/30fr/6w; Cisplatin 70mg/m2 on day 1,29; 5-FU 700mg/m2 on days 1-4, 29-32)
Interventions/Control_2
B:Low Dose concurrent chemoradiotherapy (RT: 60Gy/30fr /6w; Cisplatin 4mg/m2 and 5-FU 200mg/m2, 5 days every week, repeatedly for 6 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)Esophageal cancer histologically proven by GIF biopsy (squamons cell carcinoma, adenosquamous carcinoma, basaloid carcinoma)
2)Location of the lesion confirmed by esophagogram
i)Lesion mainly located in the thoracic esophagus
ii)Both primary lesion and intramural matastasis do not invade beyond GE junction
3)Radiotherapist determines before registration that irradiation up to 60 Gy can be completed safely.
4)Tumors are judged unresectable by CT and palpation for the following reason.
i)Primary tumor invasion depth T4
ii)Metastatic regional lymph node(s) invasion to adjacent organ.
iii)Metastatic lymph node(s) such as fixed supraclavicular or coeliac lymph node(s) provided according to the location of main tumor.
5)No distant organ metastasis.
6)Neither esophago-airway fistula nor esophago-mediastinal fistula
7)Neither Radiotherapy nor chemotherapy against any cancers. No previous therapy except EMR against esophageal cancer
8)Age from 20 to 75 years
9)Performance status of 0-2
10)Adequate organ function
11)Written informed consent
Key exclusion criteria
1)Simultaneous or metachronous (within 5 years) double cancers
2)Pregnancy or lactation
3)Serious psychiatric illness
4)Steroid treatment
5)HBs antigen positive
6)Uncontrollable diabetes
7)Myocaedial infarcion within 3 months
8)Serious comorbidity
9)Active bacterial or fungous infection
Target sample size
364
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Shinoda |
Organization
Aichi Cancer Center Hospital
Division name
Department of Thoracic Surgery
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
052-762-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Shinoda |
Organization
JCOG0303 Coordinating Office
Division name
Department of Thoracic Surgery, Aichi Cancer Center Hospital
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
052-762-6111
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.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）
国立がん研究センター東病院（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）
国立がん研究センター中央病院（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）
東海大学医学部（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
| 2007 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25640628
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
| 2004 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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
| 2007 | Year | 10 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001025
