UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047501 |
|---|---|
| Receipt number | R000054170 |
| Scientific Title | A retrospective study to explore the efficacy and safety of FOLFOX therapy and FOLFOX with radiation in esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2022/04/15 21:25:18 |
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Basic information
Public title
A retrospective study to explore the efficacy and safety of FOLFOX therapy and FOLFOX with radiation in esophageal squamous cell carcinoma
Acronym
A retrospective study to explore the efficacy and safety of FOLFOX therapy and FOLFOX with radiation in esophageal squamous cell carcinoma
Scientific Title
A retrospective study to explore the efficacy and safety of FOLFOX therapy and FOLFOX with radiation in esophageal squamous cell carcinoma
Scientific Title:Acronym
A retrospective study to explore the efficacy and safety of FOLFOX therapy and FOLFOX with radiation in esophageal squamous cell carcinoma
Region
| Japan |
Condition
Condition
esophageal squamous cell carcinoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CR rate group 1
OS group 2, 3, 4
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The diagnosis of squamous cell carcinoma, adenosquamous cell carcinoma, or basal cell carcinoma (biopsy of the secondary lesion is not required, but if biopsy is performed, the lesion must be squamous cell carcinoma, adenosquamous cell carcinoma, or basal cell carcinoma).
ECOG PS 0-2
No prior chemotherapy, radiation therapy, or surgery (Groups 1-3) (However, patients in Groups 2 and 3 are eligible if they have undergone radical therapy for at least 24 weeks after completion of treatment)
Prior cisplatin (Group 4)
Have evaluable lesions (evaluable lesions are defined as target and non-target lesions)
Treated with FOLFOX monotherapy or chemoradiotherapy with FOLFOX between April 22, 2019 and October 31, 2020. However, patients whose doses are adjusted or reduced according to their general condition in actual clinical practice regarding the standard dosage and administration of chemoradiotherapy and chemotherapy will also be accepted for enrollment.
Key exclusion criteria
Duplicate cancers (simultaneous duplicate cancers and iatrogenic duplicate cancers with a disease-free interval of 3 years or less). However, patients with overlapping cancers that are not prognostic factors are not excluded.
Patients with cardiovascular complications that are not stabilized by pharmacological therapy alone.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shiraishi |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Medical Oncology
Zip code
4600001
Address
San-no-Maru, Naka-ku, Nagoya City
TEL
0529511111
yuzushiraishi@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shiraishi |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Medical Oncology
Zip code
4600001
Address
San-no-Maru, Naka-ku, Nagoya City
TEL
0529511111
Homepage URL
yuzushiraishi@gmail.com
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center, Department of Medical Oncology
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Nagoya Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Nagoya Medical Center
Address
San-no-Maru, Naka-ku, Nagoya City
Tel
0529511111
311-rec@mail.hosp.go.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
| 2022 | Year | 04 | Month | 18 | 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
143
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
| 2021 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2022 | Year | 04 | Month | 15 | Day |
Last modified on
| 2022 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054170
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| Registered date | File name |
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| Registered date | File name |
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