UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016830 |
|---|---|
| Receipt number | R000019532 |
| 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) |
| Date of disclosure of the study information | 2015/03/17 |
| Last modified on | 2022/11/06 11:21:35 |
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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
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
in2058@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019532
