UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010561 |
|---|---|
| Receipt number | R000012345 |
| Scientific Title | Phase I Study of Docetaxel Plus Nedaplatin in Patients With Metastatic or Recurrent Esophageal Squamous Cell Carcinoma After Cisplatin Plus 5-fluorouracil Treatment |
| Date of disclosure of the study information | 2013/04/22 |
| Last modified on | 2013/04/23 14:10:27 |
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Basic information
Public title
Phase I Study of Docetaxel Plus Nedaplatin in Patients With Metastatic or Recurrent Esophageal Squamous Cell Carcinoma After Cisplatin Plus 5-fluorouracil Treatment
Acronym
Phase I Study of Docetaxel Plus Nedaplatin in Patients With Esophageal Carcinoma
Scientific Title
Phase I Study of Docetaxel Plus Nedaplatin in Patients With Metastatic or Recurrent Esophageal Squamous Cell Carcinoma After Cisplatin Plus 5-fluorouracil Treatment
Scientific Title:Acronym
Phase I Study of Docetaxel Plus Nedaplatin in Patients With Esophageal Carcinoma
Region
| Japan |
Condition
Condition
esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the optimum dose of docetaxel plus nedaplatin (cis-diammine-glycolate platinum) as second-line chemotherapy in patient with recurrent or metastatic esophageal squamous cell carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Maximum Tolerated Dose, Recommended dose
Key secondary outcomes
Toxicity, Progression 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nedaplatin Docetaxel
level0: 70mg/m2 50mg/m2
level1: 70mg/m2 60mg/m2
level2: 80mg/m2 60mg/m2
level3: 90mg/m2 60mg/m2
level4: 90mg/m2 70mg/m2
Repeat every 4 weeks
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
Patients with metastatic or recurrent esophageal SCC who had previously been treated with cisplatin plus 5-fluorouracil were enrolled in the study. The eligibility criteria were as follows: (a) histologically confirmed esophageal SCC; (b) age 20-75 years, (c) Eastern Clinical Oncology Group performance status score 0,1,2; (d) life expectancy of at least 8 weeks; (e) provision of written informed consent; (f) adequate bone marrow function (white blood cell count >=3000/mm3, platelet count >=100 000/mm3); (g) adequate hepatic function (total serum bilirubin level <=1.5 mg/dl, aspartate aminotransferase and alanine aminotransferase levels less than or equal to twice the upper limit of the normal ranges); and (h) adequate renal function (serum creatinine <=1.5 mg/dl).
Key exclusion criteria
Exclusion criteria included concomitant uncontrolled diabetes mellitus, hypertension, severe heart disease, active infection, active double cancer, massive ascites, massive pleural effusion, massive pericardial effusion, active gastrointestinal tract bleeding, possible pregnancy, brain metastases with any symptoms, severe psychological disease, and tracheoesophageal fistula formation.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kajiura |
Organization
University of Toyama
Division name
Department of Gastroenterology
Zip code
Address
2630, Sugitani, Toyama-shi, Toyama-ken, Japan
TEL
81764347301
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kajiura |
Organization
Universtiy of Toyama
Division name
Department of Gastroenterology
Zip code
Address
2630, Sugitani, Toyama-shi, Toyama-ken, Japan
TEL
81764347301
Homepage URL
shin-ya@nsknet.or.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
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
| 2013 | Year | 04 | Month | 22 | 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
| 2008 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 22 | Day |
Last modified on
| 2013 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012345
