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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030605
Receipt No. R000034937
Scientific Title Clinical study on susceptibility and side effect prediction of chemoradiotherapy for esophageal cancer by genetic analysis
Date of disclosure of the study information 2017/12/28
Last modified on 2017/12/28

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Basic information
Public title Clinical study on susceptibility and side effect prediction of chemoradiotherapy for esophageal cancer by genetic analysis
Acronym Clinical study on susceptibility and side effect prediction of chemoradiotherapy for esophageal cancer by genetic analysis
Scientific Title Clinical study on susceptibility and side effect prediction of chemoradiotherapy for esophageal cancer by genetic analysis
Scientific Title:Acronym Clinical study on susceptibility and side effect prediction of chemoradiotherapy for esophageal cancer by genetic analysis
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Fluorouracil and cisplatin combination therapy (FP therapy) therapy for patients with refractory / intolerable esophageal carcinoma in combination with docetaxel combined radiation radiotherapy and their relevance to known genetic polymorphisms will be examined.
Basic objectives2 Others
Basic objectives -Others Investigate the effects of drugs and associations between side effects and genetic polymorphisms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We investigate whether mutations / polymorphisms of ABCB1, ABCC2, SLCO1B3, CYP39A1, NEIL1 gene are predictors of tumor shrinkage effect.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Gene
Interventions/Control_1 It is conducted as an accompanying study of Clinical Phase I / II trial of Weekly Docetaxel Therapy for Simultaneous Radiation in FP Refractory / Intolerance Example of Esophageal Cancer, and treatment is also conducted according to the same test.
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) Target disease; FP therapy refractory / progression-free, Recurrent esophageal cancer
Esophageal cancer Standard surgical chemotherapy (FP therapy) was performed and recurrence within 9 months after esophageal cancer surgery
postoperative chemotherapy (FP therapy) after esophageal cancer surgery and recurrence within 9 months
Esophageal Cancer Standard case of preoperative chemotherapy (FP therapy) but judged that there is no indication for surgery
Case of FP progression intolerance (reduced renal function, platinum allergy) in advanced esophageal cancer
Example of recurrence of early metastasis outside irradiation in cases after combined chemoradiotherapy for FP
Patients who are registered in clinical studies of 'Clinical Phase I / II Studies of Weekly Docetaxel Therapy in Combined Radiation in Epilepsy FP Refractory / Intolerance cases in Esophageal Cancer'. It is impossible to participate in this research only due to the characteristics of the test.
In case
2) Regarding participation in research including provision of samples, agreement by text has been obtained from the patient himself.
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 28 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 28 Day
Last modified on
2017 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034937

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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