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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035889
Receipt No. R000040891
Scientific Title NivOlumaB and chemoradiotherapy for EsophageaL cancer
Date of disclosure of the study information 2019/02/15
Last modified on 2019/02/15

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Basic information
Public title NivOlumaB and chemoradiotherapy for EsophageaL cancer
Acronym NivOlumaB and chemoradiotherapy for EsophageaL cancer
Scientific Title NivOlumaB and chemoradiotherapy for EsophageaL cancer
Scientific Title:Acronym NivOlumaB and chemoradiotherapy for EsophageaL cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 to explored the biomarker for patients treated with chemoradiotherapy + nivolumab
Basic objectives2 Others
Basic objectives -Others Prospective study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to explored the biomarker for patients treated with chemoradiotherapy + nivolumab
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Written informed consent.
2. Aged 20 to 75 years old.
3. Histologically proven squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid cell carcinoma.
4. Primary lesions are located within the thoracic esophagus.
5. To determine before registration that definitive chemoradiotherapy can be completed safety. Patients with resectable esophageal cancer (T1N1-3M0 or T2-3N0-3M0) do not have a preference to receive a surgical resection as an initial therapy including preoperative chemotherapy.
6. No fistula (esophago-airway, esophago-mediastinal), bleeding due to artery invasion, and respiratory stenosis. Bleeding and fistula are less likely to occur during treatment.
7. No previous treatment except EMR/ESD for esophageal cancer.
8. Measurable lesions not required.
9. Neither radiotherapy, chemotherapy, nor hormone therapy against any cancers except for therapy for any cancer with more than 5 years of disease-free interval.
10. To determine before registration that definitive chemoradiotherapy can be completed safety.
11. ECOG Permormance status 0 or 1.
12. Patients must agree to biopsy when before and after starting CRT for biomarker study.
13. Adequate organ functions.
14. Women of child-bearing potential and men who are able to father a child agree with using adequate contraception. Women must not be breast feeding
Key exclusion criteria 1. Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
2. Current or past history of severe hypersensitivity to any other antibody products.
3. Active autoimmune disease.
4. Intestinal lung disease or pulmonary fibrosis
5. Diverticulitis or peptic ulcer
6. Pleural effusion or ascites necessary for emission
7. Uncontrollable tumor pain
8. Transient ischemic attack, cerebrovascular accident, thrombosis or thromboembolism within 180 days
9. Uncontrollable severe cardiovascular disease
10. Cannot biopsy using the esophagogastoroduodenoscope due to anticoagulant therapy
11. Patients requiring systemic steroid medication or the other immunosuppressive drug excluding corticosteroid drugs before 14 days.
12. Uncontrollable diabetes
13. Treating systemic infection
14. Patients received live vaccines
15. HBs antigen positive or HCV antibody positive
16. Either HBs antibody positive or HBc antibody positive and HBV-DNA detection although HBs antigen is negative
17. Females who are or may be pregnant or lactating
18. Administration of unapproved drugs within 28 days
19. Patients who are incapable of gibing consent (for example, dementia)
20. Any other inadequacy for this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Kyoto university hospital
Division name Department of Medical Oncology
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
TEL 075-751-3111
Email mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoo Nomura
Organization Kyoto university
Division name Department of Medical Oncology
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
TEL 075-751-3518
Homepage URL
Email mnomura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university hospital
Institute
Department

Funding Source
Organization Ono Pharmaceutical CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
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 国立がん研究センター中央病院(東京)、国立がん研究センター東病院(千葉)、千葉がんセンター(千葉)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 15 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
2018 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A multicenter prospective observational study

Management information
Registered date
2019 Year 02 Month 15 Day
Last modified on
2019 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040891

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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