UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044485 |
|---|---|
| Receipt number | 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 | 2024/12/12 12:07:51 |
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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
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
k.fushiki@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
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
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
Data analyses ongoing
Publication of results
Partially published
Result
URL related to results and publications
The results were partially published
Number of participants that the trial has enrolled
93
Results
The results of part B was presented in the GI ASCO 2024 meeting.
Results date posted
| 2024 | Year | 12 | Month | 11 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Delay of data analyses
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 19 | Day |
Baseline Characteristics
Thirty one patients with cStage IVB esophageal cancer was registered in part B.
Participant flow
Among the 31 patients registered, 30 patients received protocol treatment and their data was analysed.
Adverse events
Incidence of grade 3-4 adverse events were neutrophil count decreased, 7%; anaemia 3%; platelet count decreased 0%, decreased appetite, 7%; nausea, 7%; lung infection , 7%; peripheral sesory neurophathy, 3%.
Outcome measures
Response rate, 22.6%; median PFS, 3.9 months; median OS, 13.3 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050820
