UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of S-1 therapy for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Acronym	A phase II study of S-1 therapy for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Scientific Title	A phase II study of S-1 therapy for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Scientific Title:Acronym	A phase II study of S-1 therapy for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (OGSG1404)
Region	Japan

Condition
Condition	Esophageal carcinoma
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy and safety of S-1 for advanced/recurrent esophageal carcinoma resistant/intolerable to 5-FU, platinum compounds, and Taxane.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease control rate (DCR)
Key secondary outcomes	Overall survival Progression free surviva(PFS) Time to Treatment Failure(TTF) Response rate(RR) Incidence of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1: twice a day oral intake on days 1-28, followed by14 days rest.
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) histologically proven esophageal squamous cell carcinoma or esophageal adenosquamous carcinoma 2) advanced/recurrent esophageal cancer resistant /intolerable to fluoropyrimydine (exclude S-1), platinum compounds, or Taxane 3) without prior use of TS-1 4) with/withnot measurable lesions by RESIST ver. 1.1 5) 20 years of age or older 6) Performance Status by Eastern Cooperative Oncology Group of 0 or 1 7) with an expected survival period longer than 3 months from the registration 8) with a rest longer than 14 days from the end of prior therapy 9) with good functions of important organs tested within 14 days before registration 1. Neutrophil: =>1,500/mm3 2. Hemoglobin: =>8.0 g/dl 3. Platelet: =>100,000/mm3 4. T.bil.: =<1.5 mg/dL 5. AST, ALT: =< 100 IU/L 6. cleatinine clearance : =>50mL/min 10) with HBs antigen negative within 1 year, or under administration of anti-nuclear analogues by a specialist for liver diseases when HSs is positive 11) with written Informed Consent
Key exclusion criteria	1) with active double cancers excluding carcinoma in situ and/or prior cancer cured with shorter than 5 year interval period 2) with uncontrollable DM 3) with a history of cardiac infarction and/or anxiety angina pectoris within 6 months 4) with uncontrolled arrhythmia 5) under continuous steroids medication 6) with liver cirrhosis 7) with active infectious disease 8) with pericardial fluid, pleural fluid and/or ascites which needs drainage except controlled pleural fluid or ascites 9) have a history of Grade 2-4 hypersensitivity (CTCAE ver.4.0) 10) with grade 2-4 peripheral neuropathy by CTCAE v4.0 11) with blood transfusion within 2 weeks and/or continuous bleeding 12) with a figure of interstitial pneumonitis except radiation pneumonitis 13) with metastatic lesions in the central nerve 14) patient with psychological disorder who cannot participate in this study 15) women pregnant and/or nursing or men who like to have children in future 16) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takayuki Ki
Organization	Osaka Medical College
Division name	chemotherapy center
Zip code
Address	2-7,Daigakutyou,Takatsuk,City,Osaka, 569-8686
TEL	072-683-1221
Email	in2058@poh.osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takayuki Ki
Organization	Osaka Medical College
Division name	chemotherapy center
Zip code
Address	2-7,Daigakutyou,Takatsuk,City,Osaka, 569-8686
TEL	072-683-1221
Homepage URL
Email	in2058@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization	Osaka Clinical Study Supporting Organization
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
Address
Tel
Email

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	大阪医科大学（大阪府）、京都大学（京都府）、市立貝塚病院（大阪府）、市立豊中病院（大阪府）、関西労災病院（兵庫県）、八尾市立病院（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 17 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007/s10388-022-00931-8
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s10388-022-00931-8
Number of participants that the trial has enrolled	17
Results	The disease control rate(DCR) was 46.7%. The response rate was 13.3%. The median progression-free survival was 2.0 months. The median time to treatment failure was 1.9 months. The median overall survival was 8.4 months, and the 1-year overall survival rate was 30.5%.
Results date posted	2022 Year 11 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 06 Month 20 Day
Baseline Characteristics	Patients with recurrent or metastatic (R/M) esophageal squamous cell carcinoma(ESCC); no prior S-1 use; were intolerant or refractory to prior FU, PT, and TAX therapy
Participant flow	Between October 2015 and December 2017, 17 patients were recruited, and the trial was terminated because of slow accrual.
Adverse events	.
Outcome measures	The primary endpoint was the disease control rate (DCR). Secondary endpoints were overall survival, progression-free survival, time to treatment failure, response rate, and toxicity.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 07 Day
Date of IRB	2015 Year 03 Month 02 Day
Anticipated trial start date	2015 Year 10 Month 29 Day
Last follow-up date	2018 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 25 Day

Other
Other related information

Management information
Registered date	2015 Year 03 Month 17 Day
Last modified on	2022 Year 11 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019532