UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035889 |
|---|---|
| Receipt number | R000040891 |
| Scientific Title | NivOlumaB and chemoradiotherapy for EsophageaL cancer |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2022/12/19 10:37:36 |
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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
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
mnomura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university hospital
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
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
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040891
