UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003633 |
|---|---|
| Receipt number | R000001884 |
| Scientific Title | Phase 1/2 Study of Docetaxel, CDDP and 5-FU therapy in Patients With Unresectable or Recurrent Esophageal Cancer |
| Date of disclosure of the study information | 2010/05/18 |
| Last modified on | 2019/05/26 11:21:28 |
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Basic information
Public title
Phase 1/2 Study of Docetaxel, CDDP and 5-FU therapy in Patients With Unresectable or Recurrent Esophageal Cancer
Acronym
Phase 1/2 Study of Docetaxel, CDDP and 5-FU therapy in Patients With Unresectable or Recurrent Esophageal Cancer
Scientific Title
Phase 1/2 Study of Docetaxel, CDDP and 5-FU therapy in Patients With Unresectable or Recurrent Esophageal Cancer
Scientific Title:Acronym
Phase 1/2 Study of Docetaxel, CDDP and 5-FU therapy in Patients With Unresectable or Recurrent Esophageal Cancer
Region
| Japan |
Condition
Condition
Unresectable or recurrent esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommended dose of docetaxel, cisplatin and 5-FU in patients with unresectable or recurrent esophageal cancer, and to evaluate the efficacy and safety with this therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recommended dose
Dose limiting toxicity
Response rate
Key secondary outcomes
Toxicity
Time to progression
Overall survival
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
dosage level:
In phase I study, the dosege level of Docetaxel(DTX), cisplatin(CDDP) and 5FU shows table below.
DTX CDDP 5-FU
Level1 60mg/m2 70mg/m2 700mg/m2
Level2 70mg/m2 70mg/m2 700mg/m2
Level3 75mg/m2 70mg/m2 700mg/m2
In phase II study,these drugs are administered recommended amount in the result of phase I study.
Schedule:
DTX and CDDP are
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. Histologically confirmed squamous cell carcinoma of esophagus.
2. clinically confirmed T4 tumor and/or M1 LYM or M1 according to the Tumor-Node-Metastasis classification of the UICC, or recurrent esophageal carcinoma after radical esophagectomy
3. There is at least one estimative lesion.
4. Patients have never received chemotherapy and/or radiotherapy for esophageal cancer.
5. Patients of age =>20 and 75=> at the registration.
6. Performance Status:0-2(ECOG)
7. Sufficient organ functions within two weeks before registration.
1) leukocyte >=4,000/mm3 and <=12,000/mm3
2) platelets >=100,000/mm3
3) hemoglobin >=9.0g/dl (and except from administration of blood transfusion)
4) total bilirubin <=1.5mg/dl
5) AST(GOT)/ALT(GPT): within 2 times the upper limit of normal
6) total bilirubin <=1.5 mg/dl
7) creatinine clearance >=60ml/min (following Cockcroft-Gault calculus
8) SpO2 >= 95%(at room air)
8. Written informed consent.
9. It is expected that patients survive for over 3 months.
Key exclusion criteria
1. Patients have serious complications (heart disease, pulmonary fibrosis, interstitial pneumonia, hemorrhagic tendency and so on)
2. active infection
3. active synchronous malignancy
4. peripheral neuropathy or edema >= Grade 2 (CTCAE version3)
5. history of serious drug hypersensitivity
6. brain metastasis
7. pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy
8. patients who are judged inappropriate for the entry into study by the investigator
Target sample size
49
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Yamasaki |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871
TEL
06-6879-3251
Homepage URL
myamasaki@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
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
Osaka University Medical Hospital
Address
2-15, Yamadaoka, Suita City, Osaka, Japan
Tel
06-6879-5111
myamasaki@gesurg.med.osaka-u.ac.jp
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
大阪大学病院(大阪府)、大阪府立成人病センター(大阪府）、近畿大学病院(大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001884
