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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010561
Receipt No. 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

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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
Email

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
Email shin-ya@nsknet.or.jp

Sponsor
Institute University of Toyama
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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