UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030605 |
|---|---|
| Receipt number | 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 08:21:23 |
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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
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
ms01-hayashi@jikei.co.jp
Sponsor or person
Institute
The Jikei university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034937
