UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044485
Receipt No. R000050820
Scientific Title Observational study of definitive chemoradiotherapy and palliative chemotherapy using FOLFOX for esophageal squamous cell carcinoma
Date of disclosure of the study information 2021/06/09
Last modified on 2021/06/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Observational study of FOLFOX therapy for esophageal squamous cell carcinoma
Acronym OFFER
Scientific Title Observational study of definitive chemoradiotherapy and palliative chemotherapy using FOLFOX for esophageal squamous cell carcinoma
Scientific Title:Acronym OFFER
Region
Japan

Condition
Condition Esophageal squamous cell carcinoma
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of FOLFOX therapy for esophageal squamous cell carcinoma in definitive chemoradiotherapy (group A); in palliative first-line chemotherapy (group B); in salvage chemotherapy after another platinum refractory (group C)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Group A: Complete response rate
Group B and C: response rate
Key secondary outcomes Overall survival, progression free survival, adverse events

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Cervical or thoracic esophageal cancer, or esophagogastric junction cancer (UICC 8th)
2. Histologically proven squamous cell carcinoma
3. Intolerable to cisplatin and planned either of the treatment: definitive chemoradiotherapy for stage I-IVA disease; palliative first-line chemotherapy for stage IVB or recurrent disease; salvage chemotherapy after refractory to another platinum for stage IVB or recurrent disease
4. No previous use of oxaliplatin
5. 20 years or older
6. ECOG performance status 0, 1, 2
7. Adequate organ functions
8. Obtained informed consent
Key exclusion criteria Patient who does not satisfy inclusion criteria
Target sample size 93

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Tsushima
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal Oncology
Zip code 411-8777
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 0559895222
Email t.tsushima@scchr.jp

Public contact
Name of contact person
1st name Kunihiro
Middle name
Last name Fushiki
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal Oncology
Zip code 411-8777
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 0559895222
Homepage URL
Email k.fushiki@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shizuoka Cancer Center
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel 0559895222
Email tansaku_office@scchr.jp

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
2021 Year 06 Month 09 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 Enrolling by invitation
Date of protocol fixation
2020 Year 12 Month 18 Day
Date of IRB
2020 Year 12 Month 25 Day
Anticipated trial start date
2021 Year 03 Month 17 Day
Last follow-up date
2023 Year 03 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 06 Month 09 Day
Last modified on
2021 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050820

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.