UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004856 |
|---|---|
| Receipt number | 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 07:41:20 |
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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
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
nino@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Gastroenterologic surgery, Kanazawa university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005765
