UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002137 |
|---|---|
| Receipt number | R000002555 |
| Scientific Title | PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer. |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2020/03/19 16:24:08 |
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Basic information
Public title
PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer.
Acronym
PhaseI/II trial of neoadjvant chemoradiotherapy with DCF in patients with advanced esophageal cancer.
Scientific Title
PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer.
Scientific Title:Acronym
PhaseI/II trial of neoadjvant chemoradiotherapy with DCF in patients with advanced esophageal cancer.
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| 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 and radiotherapy follwed by surgery in patients with advanesd esophageal cancer.
Phase II part: to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy with docetaxel, cisplatin and 5-FU follwed by surgery in patients with advanced esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
PhaseI:Incidence of dose limiting toxicity
PhaseII:Histopathological response rate
Key secondary outcomes
PhaseI:Adverse events,Histopathological response rate
PhaseII:Adverse events, Disease-free survival, Overall 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 | Device,equipment | Maneuver |
Interventions/Control_1
Radiotherapy(2Gy/5day/week) is begun within 24 hours of the administration of chemotherapy, and continue for 4 weeks(40Gy).
Combination chemotherapy consists of docetaxel (25,30,35,40 mg/m2/day, day 1,15,29 and day 43), cisplatin (70 mg/m2/day, day 1,29), and 5-FU (700mg/m2/day, days 1 through 4 and days 29-32).
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 esophageal carcinoma.
2.Lesion located within the radiation field.
3.Primary lesion with penetration of muscularis propiria, excluding T4 lesion and distant metastasis.
4.Measurable lesion
5.No previous therapy against esophageal cancer.
6.No previous radiotherapy within the radiation field.
7.ECOG Performance status 0 or 1
8.Aged 20 to 75 years old
9.Expected to survive more than 3 months
10.Written informed consent
Key exclusion criteria
1.History of hypersensitivity to DOC, CDDP, 5-FU, or polysorbate 80
2.With severe complication
3.Infection with fever elevation
4.Motor paralysis, peripheral neuropathy or edema
5.Pleural or pericardial effusion that requires treatment
6.Simultaneous or metachronous (within 5 years) double cancers.
7.Pregnant or lactating women
8.Interstitial pneumonia or fibroid lung
9.Psychosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Morihito |
| Middle name | |
| Last name | Okada |
Organization
Research Institute for Radiation Biology and Medicine Hirosima University
Division name
Surgical Oncology
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima 734-8551 Japan
TEL
082-257-5869
morihito1217@gmail.com
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Emi |
Organization
Research Institute for Radiation Biology and Medicine Hirosima University
Division name
Surgical Oncology
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima 734-8551 Japan
TEL
082-257-5869
Homepage URL
moaista@hotmail.com
Sponsor or person
Institute
Department of Surgical Oncology, Division of Clinical and Experimental Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgical Oncology, Division of Clinical and Experimental Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University hospital Center of Integrated Medical Research
Address
Kasumi 1-2-3, Minami-Ku, Hiroshima 734-8553, Japan
Tel
082-257-1752
protocol@cimr.hiroshima-u.ac.jp
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
| 2009 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | 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 | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002555
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