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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004856
Receipt No. R000005765
Scientific Title Phase I/II trial of weekly docetaxel and concomitant radiotherapy for unresectable esophageal squamous cell carcinoma after induction chemothrapy
Date of disclosure of the study information 2011/01/15
Last modified on 2014/07/15

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Basic information
Public title Phase I/II trial of weekly docetaxel and concomitant radiotherapy for unresectable esophageal squamous cell carcinoma after induction chemothrapy
Acronym Phase I/II trial of docetaxel and concomitant radiotherapy for unresectable esophageal carcinoma
Scientific Title Phase I/II trial of weekly docetaxel and concomitant radiotherapy for unresectable esophageal squamous cell carcinoma after induction chemothrapy
Scientific Title:Acronym Phase I/II trial of docetaxel and concomitant radiotherapy for unresectable esophageal carcinoma
Region
Japan

Condition
Condition Unresectable esophageal squamous cell carcinoma after induction chemotherapy
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objectives of the phase I study are to determine the maximum tolerated dose and the optimal dose of Docetaxel when administered concomitantly with radiation. In the phase II study, the objective was to define the effect and toxicities of Docetaxel with radiation in the treatment for unresectable esophageal squamous cell carcinoma after induction chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: To determine the maximaum tolerated dose (MTD) and recommended dose (RD) of Docetaxel
Phase II: 2 year survival rate
Key secondary outcomes Phase I: response rate

Phase II: complete remission rate, progression free survival, the rate of occurrence of adverse event, the rate of occurrence of late adverse event

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 Other
Interventions/Control_1 Docetaxel
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) 20-75 years of age.
2) Thoracic esophageal squamous cell carcinoma.
3) Unresectable state (T4 or N4) after induction chemotherapy.
4) With or without multiple lesions or intramucosal extension.
5) Without the tumor extension to cervical esophagus or gastric cardia.
6) Without distant metastasis.
7) No prior treatment except planned induction chemotherapy for esophageal cancer.
8) With a performance status of 0 or 1.
9) No major organ function abnormality.
Laboratory measurements required at study registration include the followings: white blood cells, >3000/mm3; hemoglobin, >9.0 g/dL; GOT and GPT, <100 IU; total bilirubin, >2.0 mg/dL; arterial oxygen pressure, >60 Torr; serum creatinine, >1.2 mg/dL and creatinine clearance, >60 ml/mn.
10) Written informed consent is obtained before registration.
Key exclusion criteria 1) The presence of esophageal fistula
2) The presence of severe combined diseases including hear failure, renal failure, hepatic failure and uncontrollable diabetes mellitus.
3) Active infectious diseases (exept HBV or HCV infection).
4) Previous radiotherapy to chest.
5) Apparent interstitial pneumonia or lung fibrosis.
6) Combined active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment.
7) The presence of motor paralysis, peripheral neuropathy or edema.
8) No usage of contraceptive method for patients with reproductive age.
9) The presence of mental disease or disorder with difficulty in participating in the clinical trial.
10) Inadequate for clinical trial entry by the attending physicians.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itasu Ninomiya
Organization Kanazawa university hospital
Division name Gastroenterologic surgery
Zip code
Address Takaramachi 13-1, Kanazawa
TEL 076-265-2362
Email nino@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Itasu Ninomiya
Organization Kanazawa university
Division name Gastroenterologic surgery
Zip code
Address Takaramachi 13-1, Kanazawa
TEL 076-265-2362
Homepage URL http://web.kanazawa-u.ac.jp/~med26/index.htm
Email nino@staff.kanazawa-u.ac.jp

Sponsor
Institute Gastroenterologic surgery, Kanazawa university
Institute
Department

Funding Source
Organization Digestive disease support organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 金沢大学附属病院(石川県)、金沢医科大学附属病院(石川県)、福井大学附属病院 (福井県)、富山県立中央病院(富山県)、石川県立中央病院(石川県)、厚生連高岡病院(富山県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 15 Day

Related information
URL releasing protocol http://ddso.web.fc2.com/
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 Terminated
Date of protocol fixation
2010 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2015 Year 01 Month 01 Day
Date of closure to data entry
2015 Year 01 Month 01 Day
Date trial data considered complete
2015 Year 01 Month 01 Day
Date analysis concluded
2015 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 11 Day
Last modified on
2014 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005765

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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