UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003534 |
|---|---|
| Receipt number | R000004179 |
| Scientific Title | A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3) |
| Date of disclosure of the study information | 2010/04/26 |
| Last modified on | 2014/08/08 17:01:45 |
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Basic information
Public title
A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)
Acronym
A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)
Scientific Title
A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)
Scientific Title:Acronym
A non-randomized confirmatory study of definitive chemoradiotherapy including salvage treatment in patients with clinical stage II/III esophageal carcinoma (JCOG 0909,EC-CRT+Salvage-sP3)
Region
| Japan |
Condition
Condition
esophageal neoplasm
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of deffenitive chemoradiotherapy with 5-FU plus cisplatin including salvage treatment in patients with clinical stage II/ III esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Proportion of 3-year overall survival
Key secondary outcomes
progression-free survival, complete response rate, adverse events, delayed toxicity, salvage treatment related toxicity, esophagectomy-free survival
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
Chemoradiotherapy consists of 5-FU (1,000 mg/m2, day1-4, day29-32), cisplatin (75 mg/m2, day1,29) and radiotherapy (50.4 Gy/28Fr), followed by adittional two courses chemotherapy with 5-FU (1,000 mg/m2, day1-4) plus cisplatin (75 mg/m2, day1). Salvage therapy including salvage surgery and/or salvage endoscopic mucosal resection is applied if the patient has residual tumor or recurrent tumor after definitive chemoradiotherapy.
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) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma
2) All lesions located in the thoracic esophagus
3) Clinical stageII or III without T4
4) Aged 20 to 75 years old
5) ECOG Performance status 0 or 1
6) No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM(pM2)/pT1a-MM(M3) disease or pT1a-MM(M3) disease without vascular infiltration
7) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval
8) Adequate organ functions
9) Patients do not have a preference to receive a surgical resection as an initial therapy including preoperative chemotherapy, but agree to receive a salvage treatment including surgery when the disease is residual or recurrent
10) Written informed consent
Key exclusion criteria
1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Active infection requiring systemic therapy
3) fever over 38 degrees Celsius
4) Pregnant or lactating women or women of childbearing potential
5) Psychosis
6) Patients requiring systemic steroids medication
7) Serum HBs antigen positive
8) Diabetes mellitus with HbA1c of 7.0% or higher
9) Uncontrollable hypertention
10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
11) Interstitial pneumonia, fibroid lung, or severe emphysema
12) With a history of cerebrovascular disorder within 6 months
13) Drug allergy for iodic drug
Target sample size
95
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Kitagawa |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanoi-Chou, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Ito |
Organization
JCOG0909 Coordinating Office
Division name
National Cnacer Center Hosipital, division of radiation oncology
Zip code
Address
5-1-1Tsukiji, Chuo-ku, Tokyo, 105-0043, Japan.
TEL
03-3542-2511
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）
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）
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）
東京医科歯科大学（東京都）
がん研究会有明病院（東京都）
虎の門病院（東京都）
東海大学医学部（神奈川県）
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）
富山大学付属病院（富山県）
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）
大阪大学医学部（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）
広島大学病院（広島県）
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）
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2014 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004179
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