UMIN-CTR Clinical Trial

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
Email	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
Email	yuzushiraishi@gmail.com

Sponsor
Institute	National Hospital Organization Nagoya Medical Center, Department of Medical Oncology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054170