UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004223 |
|---|---|
| Receipt number | R000005074 |
| Scientific Title | Feasibility study of Neoadjuvant chemoradiotherapy for locally advanced esophageal carcinoma |
| Date of disclosure of the study information | 2010/09/16 |
| Last modified on | 2018/10/31 22:37:13 |
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Basic information
Public title
Feasibility study of Neoadjuvant chemoradiotherapy for locally advanced esophageal carcinoma
Acronym
NeoCRT trial
Scientific Title
Feasibility study of Neoadjuvant chemoradiotherapy for locally advanced esophageal carcinoma
Scientific Title:Acronym
NeoCRT trial
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of neoadjuvant chemoradiotherapy with 5-FU and CDDP for resectable locally advanced esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Completion proportion of curative surgery
Key secondary outcomes
Overall survival, Progression free survival, curative resection rate,
Response rate for CRT
Pathological CR rate
Acute toxicity
Late toxicity
Surgical toxicity
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 |
Interventions/Control_1
Chemoradiotherapy(5-FU+CDDP+RT)
Surgery
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)Historically proven squamous cell or adeon-squamous cell carcinoma.
2)Thoracic esophageal cancer
3)Clinical T2-3N0M0 or T1-3N1M0 (UICC6th)
4)Age more than 20years and less than 75 years.
5)ECOG performance status of 0,1 or 2.
6)Patients who had any evaluable lesion.
7)No prior therapy for esophageal cancer except curative endoscopic therapy.
8)No prior chemotherapy or radiotherapy for other cancr.
9)No palsy of recurrent nerve
10)Required baseline laboratory parameters (within 7 days before registration):
Hb more than 10.0g/dl
Neutrophil more than 2000/ul
Plt more than 100,000/ul
T-Bil less than 1.5mg/dl
GOT less than 100 IU/l
GPT less than 100 IU/l
Ccr more than 60mg/min
11)The patients who were considered to be undergone transthoracic esophagectomy with D2 lymphonode dissection.
12)Signed informed consent of the patient for the registration.
Key exclusion criteria
1)active other malignancies within 5 years
2)Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse.
3)Unsuitable mental status and condition for clinical trials.
4)Patients who received ontinuous steroids (orally or intravenous) administration.
5)Positive HBsAg.
6)Unstable diabetes mellitus with oral hypoglycemic agent or insulin.
7)Acute myocardial infarction within 3 months
8)severe complications (COPD, interstitial lung disease, pulmonary fibrosis, heart failure and so on)
9)clinically significant infectious disease(body temperature less than 38.0 degrees)
10)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Kato |
Organization
National Cancer Center Hospital
Division name
Gastrointestinal Oncology Division
Zip code
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3542-2511
kenkato@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Hashimoto |
Organization
National Cancer Center Hospital
Division name
Gastrointestinal Oncology Division
Zip code
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3542-2511
Homepage URL
kenkato@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
国立がん研究センター中央病院(東京都）
国立がん研究センター東病院（千葉県）
栃木県立がんセンター（栃木県）
静岡県立静岡がんセンター（静岡県）
千葉大学医学部(千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005074
