UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017685 |
|---|---|
| Receipt number | R000019570 |
| Scientific Title | Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer |
| Date of disclosure of the study information | 2015/05/27 |
| Last modified on | 2018/05/28 12:35:44 |
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Basic information
Public title
Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer
Acronym
UDON P-II
Scientific Title
Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer
Scientific Title:Acronym
UDON P-II
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effectiveness of the 5FU/ docetaxel / nedaplatin combination therapy for the esophageal cancer that radical radiation therapy is impossible having a recurrence case or remote metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival
overall survival
adverse event
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
Combination chemotherapy consists of docetaxel (35 mg/m2/day, day 1 and day 15), nedaplatin (90 mg/m2/day, day 1), and 5-FU (800mg/m2/day, days 1 through 5). The treatment is repeated every 4 weeks until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Primary tumor located at cervical esophagus, thoracic esophagus or esophago-gastric junction.
2)Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or basaloid carcinoma.
3)Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy.
a)In case of unresectable esophageal cancer, all of the following conditions must be fulfilled:
i)Having metastatic lesion except for #102 or #104 metastases
ii)cT1-cT4a
iii)Dysphagia score =<2 and no stenosis which endoscope does not pass through
b)In case of recurrent esophageal cancer, all of the following conditions must be fulfilled:
i)Having metastatic lesion except for #102 or #104 metastases.
ii)Dysphagia score =<2.
4)Older than 20 years old.
5)ECOG PS of 0,1 or 2.
6)Measurable lesion is required.
7)Neither previous chemotherapy ,chemoradiotherapy,nor radiotherapy against any cancer
8)Adequate organ function
9)Without symptomatic brain metastasis
10)Without moderate or more ascites/pleural effusion
11)Written informed consent
Key exclusion criteria
1)Poorly controlled diabetes mellitus or routine administration of insulin.
2)Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
3)History of hypersensitivity to 5FU, DOC, CDGP, or polysorbate 80.
4)Active infection requiring systemic therapy.
5)Patients requiring systemic steroid medication.
6)Motor paralysis or peripheral neuropathy by any reason.
7)Edema by any reason.
8)Severe pulmonary fibrosis or emphysema.
9)A case with the past of radiotherapy or the chemotherapy within two weeks before registration.
10)With moderate or more ascites/pleural effusion or pericardial fluid.
11) Severe cardiac disease , or with a history of myocardial infarction within 6 months , or poorly controlled hypertension.
12)A case to have the past of the cerebrovascular disorder that developed within six months.
13)A case to have diarrhea continuously.
14)Case having the intestinal tract paralysis, ileus
15)Positive HBs antigen , or positive HIV antibody.
16)The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination.
17) During the pregnancy or a pregnant female patient we are possible or are nursing.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIROTO UEDA |
Organization
Kinki university Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2,ohnohigashi,osakasayamashi,osaka
TEL
072-366-0221
h-ueda@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIROTO UEDA |
Organization
Kinki University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2,ohnohigashi,osakasayamashi,osaka
TEL
072-366-0221
Homepage URL
h-ueda@med.kindai.ac.jp
Sponsor or person
Institute
Kinki university Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 27 | 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
| 2014 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019570
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