UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on susceptibility and side effect prediction of chemoradiotherapy for esophageal cancer by genetic analysis
Title of the study (Brief title)	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	Kazumi Hayashi
Organization	The Jikei university school of medicine
Division name	Department of Hematology and Oncology
Address	3-25-8 Nishi-shinbashi minatoku tokyo
TEL	0334331111
Email	ms01-hayashi@jikei.co.jp

Public contact
Name of contact person	Kazumi Hayashi
Organization	The Jikei University school of medicine
Division name	Department of Hematology and Oncology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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