UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005588 |
|---|---|
| Receipt number | R000006012 |
| Scientific Title | Phase II study of neoadjuvant and adjuvant docetaxel/cisplatin/5-fluorouracil in resectable esophagus cancer |
| Date of disclosure of the study information | 2011/05/13 |
| Last modified on | 2015/06/18 15:50:05 |
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Basic information
Public title
Phase II study of neoadjuvant and adjuvant docetaxel/cisplatin/5-fluorouracil in resectable esophagus cancer
Acronym
Phase II study of neoadjuvant and adjuvant docetaxel/cisplatin/5-fluorouracil in resectable esophagus cancer
Scientific Title
Phase II study of neoadjuvant and adjuvant docetaxel/cisplatin/5-fluorouracil in resectable esophagus cancer
Scientific Title:Acronym
Phase II study of neoadjuvant and adjuvant docetaxel/cisplatin/5-fluorouracil in resectable esophagus cancer
Region
| Japan |
Condition
Condition
esophagus cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and feasibility, we conduct phase II study of neoadjuvant and adjuvant docetaxel/cisplatin/5-fluorouracil chemotherapy in patients with resectable stage II/III esophagus cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
objective response rate of neoadjuvant chemotherapy
Key secondary outcomes
pathological response, overall survival, progression free survival, adverse events, feasibility
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
Two courses of docetaxel/cisplatin/5-fluorouracil chemotherapy (docetaxel 60mg/sm day1, cisplatin 70mg/sm day1, 5-fluorouracil 600mg/sm day 1 to 5) are given separated by 4-week interval, prior to the surgery. If metastatic lymph node are identified by pathologic examination, additional two courses of postoperative chemotherapy are administered, by 4-week interval.
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) Resectable esophagus carcinoma stage II/III with no prior therapy.
(2) Measurable target lesions by RECIST guidelines.
(3) Pathologically proven squamous cell carcinoma of the esophagus.
(4) Written informed consent is obtained.
(5) An age of 20 to 75 years.
(6) An ECOG performance status of 0 to 2.
(7) Eligible for surgery with curative intent.
(8) Life expectancy exceeding at least 3 months.
(9) Major organs are in normal conditions.
Hemoglobin => 9.0g/dL
White blood cell count 4,000 to 12,000/mm3
Platelet count => 100,000/mm3
Serum bilirubin <= 1.5 times upper limit of normal
AST, ALT <= 2.5 times upper limit of normal
ALP <= 2.5 times upper limit of normal
Serum creatinine <= upper limit of normal
Creatinine clearance (or estimated GFR) => 60mL/min
Key exclusion criteria
(1) Known hypersensitivity to taxanes, platinum, fluoropyrimidines. Known dihydropyrimidine-dehydrogenase (DPD) deficit.
(2) Pre-existing motor or sensory neurotoxicity of a severity => Grade2 (CTCAE v4.0)
(3) Active infectious diseases.
(4) Symptomatic bleeding tendency, coagulation disorder, or coagulation factor deficiency.
(5) Uncontrollable hypertension, uncontrollable diabetes, unstable angina, or heart failure.
(6) Pre-existing renal insufficiency or proteinuria => 2+.
(7) Clinical or radiographic signs of interstitial pneumonia or pulmonary fibrosis.
(8) Active gastrointestinal bleeding, bowel obstruction.
(9) Severe mental disorders, neurological disease
(10) Pregnant or lactation women, or women with the possibility of the pregnancy.
(11) Men who want let to pregnancy.
(12) Patients who are judged inappropriate for the entry into this study by the investigator.
(13) Active synchronous or metachronous malignancy, excepting for early stage cancers of the oral cavity, pharynx, larynx and early (stage Ia) gastric cancer.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunori Nishikawa |
Organization
Jikei university school of medicine
Division name
Department of surgery
Zip code
Address
3-19-18 Nishi-shimbashi Minato-Ku Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jikei university school of medicine
Division name
Department of surgery
Zip code
Address
3-19-18 Nishi-shimbashi Minato-Ku Tokyo Japan
TEL
Homepage URL
esophagus@jikei.ac.jp
Sponsor or person
Institute
Jikei university of medicine department of surgery, department of oncology and hematology
Institute
Department
Personal name
Funding Source
Organization
Jikei university of medicine department of surgery, department of oncology and hematology
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
慈恵医大附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 13 | 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
| 2011 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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
| 2011 | Year | 05 | Month | 11 | Day |
Last modified on
| 2015 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006012
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