UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016364 |
|---|---|
| Receipt number | R000019003 |
| Scientific Title | Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2022/08/04 16:53:50 |
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Basic information
Public title
Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer
Acronym
Phase I/II trial of chemotherapy with modified DCS
Scientific Title
Phase I/II trial of chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced esophageal cancer
Scientific Title:Acronym
Phase I/II trial of chemotherapy with modified DCS
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This phase I/II study is being conducted to determine the safety and the efficacy of chemotherapy using docetaxel, cisplatin and S-1 (DCS) for unresectable advanced esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Safety (Toxicities as assessed by NCI CTCAE ver. 4)
Phase II: Clinical response of chemotherapy(Feasibility as evaluated by RECIST ver 1.1)
Key secondary outcomes
Phase II: Toxicities as assessed by NCI CTCAE ver. 4
Time to progression
Median survival time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chemotherapy using Docetaxel+Cisplatin+S-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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients with locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan.
(2)ECOG perfprmance status 0-1.
(3)Tissue from tumor must be available. Patients must have measurable disease.
(4)Patients may have received prior chemotherapy or radiotherapy; this must have beed completed at least 4 weeks. Patients may have received prior surgery or ESD; this must have beed completed at least 3 weeks. Patients may have received prior immunotherapy; this must have beed completed at least 1 week.
(5)Life expectancy > 3 months.
(6)Laboratory values as follows.
2000/mm3 < WBC < 12000/mm3
granulocyte count > 1500/mm3
hemoglobin > 8.0 g/dl
Platelet count > 100000/mm3
AST ALT < 150 IU/L
T-bil < 1.5 mg/dl
Creatinine < 1.5
Key exclusion criteria
(1)Pregnency.
(2)Active or uncontrolled infection.
(3)Patients with a history of myocardial infarction within the previous 3 months.
(4)Patients with uncontrolled diabetes melitus or hypertension.
(5)Patients with clinically apparent central nervous system metastases
(6)Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Japan
TEL
073-441-0613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Second Department of Surgery, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Second Department of Surgery, Wakayama Medical University
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
Second Department of Surgery, Wakayama Medical University
Address
Kimiidera 811-1
Tel
0734410613
tojima@wakayama-med.ac.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
| 2015 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Oncology 2018;95:116
Publication of results
Partially published
Result
URL related to results and publications
Oncotarget, 2019, Vol. 10, (No. 8), pp: 847-855
Number of participants that the trial has enrolled
50
Results
Results: In the phase I trial, the recommended dose for docetaxel, cisplatin, and
S-1 were 40 mg/m2 (day 1), 50 mg/m2 (day 1), and 80 mg/m2/day, respectively.
In the phase II trial (n = 50), the ORR was 54 %. The median OS and PFS were 10
and 4 months, respectively. Grade 3/4 adverse events included neutropenia (26%),
leukopenia (14%), anorexia (10%) and febrile neutropenia (6%).
Results date posted
| 2022 | Year | 08 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 01 | Month | 03 | Day |
Baseline Characteristics
Although triplet regimen of docetaxel, cisplatin, and 5-FU (DCF)
reportedly yields high response rates for metastatic squamous cell carcinoma of
the esophagus (SCCE), it has severe toxicity. In our previous phase II trial, grade
3/4 toxicities of neutropenia occurred in 68.8% of the patients. Development of
chemotherapeutic regimen that does not impair quality of life of the patients with
metastatic SCCE is therefore needed. A novel chemotherapeutic regimen combining
docetaxel, cisplatin, and alternate-day administration of S-1 (modified DCS) may be
associated with reduction of severe adverse effects.
Participant flow
This study is a single center phase I/II trial of chemotherapy using modified DCS regimen for patients with recurrent/unresectable SCCE. The phase I trial adopts a 3 plus 3 patient cohort dose-escalating study design. In the phase II trial, the primary endpoint is evaluation of the overall response rate (ORR).
Secondary endpoints are evaluation of drug-related toxicity, overall survival (OS),
and progression-free survival (PFS).
Adverse events
Grade 3/4 adverse events included neutropenia (26%), leukopenia (14%), anorexia (10%) and febrile neutropenia (6%).
Outcome measures
In the phase II trial, the primary endpoint is evaluation of the overall response rate (ORR).
Secondary endpoints are evaluation of drug-related toxicity, overall survival (OS),
and progression-free survival (PFS).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 28 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019003
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