UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000856 |
|---|---|
| Receipt number | R000001030 |
| Scientific Title | Phase II trial of chemoradiotherapy (50.4Gy, modified 5-FU+CDDP) for clinical Stage II/III esophageal carcinoma |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2022/08/01 10:08:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II trial of chemoradiotherapy (50.4Gy, modified 5-FU+CDDP) for clinical Stage II/III esophageal carcinoma
Acronym
Stage II/III esophageal carcinoma: CRT based on the RTOG regimen Phase II
Scientific Title
Phase II trial of chemoradiotherapy (50.4Gy, modified 5-FU+CDDP) for clinical Stage II/III esophageal carcinoma
Scientific Title:Acronym
Stage II/III esophageal carcinoma: CRT based on the RTOG regimen Phase II
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 50.4Gy, modified 5-FU+CDDP chemoradiotherapy for clinical stage II/III (non T4) esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1-year survival rate
Key secondary outcomes
3-year survival rate, progression free survival, CR rate, toxicity rate, late toxicity rate
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
50.4Gy, modified 5-FU+CDDP 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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Thoracic esophageal cancer siagnosed as squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma.
2. Clinical UICC-stageII/III (non-T4)
3. No prior therpy for esophageal cancer and no chemotherapy for other disease
4. PS(ECOG): 0, 1
5. Not to select surgery
6. Written informed consent
7. Normal bone marrow, liver and renal function
Key exclusion criteria
1. Fistula
2. Sever complications
3. Active infection
4. Past history of radiotherapy of chest
5. Intersitial pneumonia or fibrosis
6. Active double cancer
7. Pregnancy
8. Mental illness
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Kato |
Organization
National Cancer Center Hospital, Tokyo
Division name
Gastrointestinal Oncology
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Eguchi Nakajima |
Organization
National Cancer Center Hospital, Tokyo
Division name
Outpatient Oncology
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
taeguchi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Tokyo
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital, Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka Cancer Center, Kyushu University, Jichi Medical University, Kitasato University, Aichi Cancer Center, Osaka City Medical Center, Tochigi Cancer Center, Hokkaido University
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Terminated
Date of protocol fixation
| 2006 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2006 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | 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 | 18 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001030
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
