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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030593
Receipt No. R000034936
Scientific Title Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer
Date of disclosure of the study information 2017/12/27
Last modified on 2017/12/27

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Basic information
Public title Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer
Acronym Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer
Scientific Title Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer
Scientific Title:Acronym Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I part:
We clarified the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of docetaxel dose of docetaxel in simultaneous radiation combination therapy in patients with refractory / intolerant FP therapy in esophageal cancer and recommended one dose lower than MTD Dose (RD) is taken.
Phase II part:
For 40 cases (including Phase I), treat with docetaxel recommended dose and evaluate the efficacy and safety of docetaxel therapy combined with radiation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes phase 1 part:
DLT expression rate
phase 2 part:
Response rate
Key secondary outcomes

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 Phase 1 part:
The dose of docetaxel is initially set at 10mg /m2/day (level1) and the number of cases is increased and the dose escalation is increased by5mg/m2/day according to the expression status of dose limiting toxicity (DLT) in one cycle. We administered 3 cases at each level, and after 1 cycle of the final case, based on the results of all cases to which said dose was administered, shift to the next level add the number of cases judge the maximum tolerated dose
Phase 2 part
In phase II, chemoradiotherapy is performed in a new case using the recommended dosage of docetaxel obtained in Phase I part. The safety and effectiveness of the test treatment are judged by periodically conducting an image such as blood test or CT or upper gastrointestinal endoscopy
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) The primary lesion is either cervical or thoracic esophagus (TNM classification).
2) Histopathologically it has been diagnosed as squamous cell carcinoma.
3) FP therapy refractory / intolerance.
4) The age of the registration date is 20 years old to 80 years old.
5) ECOG Performance status is 0 to 2.
6) Organ function is maintained.
7) There is no symptomatic brain metastasis.
8) Patients with a history of operation had esophageal cancer for total esophageal cancer cases in which more than 2 weeks had passed since gastric tube reconstruction
9) Cases in which survival is predicted to be at least 3 months or more from the date of registration
10) Cases in which an examination value within 14 days before registration (not including the registration date) satisfies the following criteria
Hemoglobin 8.0 g / dL or more
White blood cell 3,000 to 13,000 / mm 3
Neutrophils 1,500 / mm 3 or more
Platelets 100,000 / mm 3 or more
Total bilirubin 1.5 mg / dL or less
AST 100 IU / L or less, provided that it has liver metastasis, up to 5 times the upper limit of the facility reference value is allowed
ALT 100 IU / L or less, provided that it has liver metastasis, up to 5 times the upper limit of the facility reference value is allowed
11) Hospitalization treatment and outpatient treatment are not limited
12) Regarding the participation of this study, consent from the person in writing is obtained.
Key exclusion criteria 1) Patients receiving transfusions, blood products and hematopoietic factor preparations such as G-CSF within 14 days before registration
2) Cases with infections or diseases requiring systemic administration of antibiotics, antifungal agents
3) Cases with complications as shown below
Control poor hypertension, diabetes
Severe lung disease (interstitial pneumonia, pulmonary fibrosis, advanced emphysema, etc.)
Liver failure
Gastrointestinal bleeding that requires treatment
4) Patients with marked electrocardiogram abnormality or cases with clinically problematic heart disease
Cases with congestive heart failure, symptomatic coronary artery disease, poorly controlled arrhythmia, a history of myocardial infarction that developed within the last 12 months, etc
5) Cases with psychiatric disorder judged by the investigator or test sharing doctor to have acquired consent or adversely affect test performance
Control malfunctioning epileptic seizures, central nervous system disorders, etc.
6) Cases with moderate or more ascites (above the pelvic cavity) or with large pleural effusions
7) Cases with brain metastasis or suspected brain metastasis from clinical symptoms
8) Cases with extensive bone metastases
9) Cases with active duplicated cancers
10) HIV antibody positive cases
11) Patients who received treatment with another study drug within 4 weeks before registration of this study or participate in other clinical trials (incidental study of this study "Esophageal cancer chemical radiation by genetic analysis Clinical research on susceptibility of therapy and prediction of side effects "excluding)
12) Cases judged unsuitable as subjects of the examination by the investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumi Hayashi
Organization The Jikei University school of medicine
Division name Department of Hematology and Oncology
Zip code
Address 3-25-8 Nishi-shinbashi minatoku tokyo
TEL 0334331111
Email ms01-hayashi@jikei.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Hayashi
Organization The Jikei University school of medicine
Division name Department of Hematology and Oncology
Zip code
Address 3-25-8 Nishi-shinbashi minatoku tokyo
TEL 0334331111
Homepage URL
Email ms01-hayashi@jikei.co.jp

Sponsor
Institute The Jikei University school of medicine
Institute
Department

Funding Source
Organization self funding
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
2017 Year 12 Month 27 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 11 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
2017 Year 12 Month 27 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034936

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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