UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032257 |
|---|---|
| Receipt number | R000030084 |
| Scientific Title | Phase I/II study of bi-weekly docetaxel and cisplatin plus S-1 (bi-weekly DCS) as first-line therapy for advanced esophageal cancer. |
| Date of disclosure of the study information | 2018/04/16 |
| Last modified on | 2023/10/20 09:20:23 |
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Basic information
Public title
Phase I/II study of bi-weekly docetaxel and cisplatin plus S-1 (bi-weekly DCS)
as first-line therapy for advanced esophageal cancer.
Acronym
Phase I/II study of bi-weekly DCS as first-line therapy for advanced esophageal cancer.
Scientific Title
Phase I/II study of bi-weekly docetaxel and cisplatin plus S-1 (bi-weekly DCS)
as first-line therapy for advanced esophageal cancer.
Scientific Title:Acronym
Phase I/II study of bi-weekly DCS as first-line therapy for advanced esophageal cancer.
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I/II study of bi-weekly docetaxel and cisplatin plus S-1 (bi-weekly DCS)
as first-line therapy for advanced esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PhaseI part: DLT
PhaseII part:PFS
Key secondary outcomes
PhaseI part: Adverse Event
PhaseII part: Overall survival(OS), Response rate(RR), Adverse Event, Quality of life(QOL)
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
bi-weekly docetaxel and cisplatin plus S-1 (bi-weekly DCS)
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)Primary tumor located cervical esophagus (Ce) or thoracic esophagus (Te) according to the 7th UICC-TNM classification
2)Histologically confirmed esophageal squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma
3)Unresectable advanced or recurrent tumor with no indication for definitive treatment (surgery, radiotherapy, and chemoradiotherapy)
4)Age over 20 years old.
5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
6)Without symptomatic bone or brain metastases
7)Without massive pleural effusion (more than half of one side thoracic cavity) nor massive ascites (more than from pelvic cavity to upper abdomen)
8)With evaluable lesions according to RECIST ver 1.1 (measurable lesions not required)
9)As for previous therapy for esophageal cancer, either A) or B) must be fulfilled:
A)When preoperative chemotherapy or postoperative chemotherapy was given as previous therapy, meet all of the following 4 factors:
a.Recurrence was detected more than 24 weeks after previous therapy was completed
b.Previous therapy was not terminated due to adverse events, patient refusal
c.Tumor response by previous therapy was not judged as disease progression
d.Total dose of prior CDDP =<210 mg/m2
B)When preoperative chemoradiotherapy, concurrent chemoradiotherapy or radiotherapy alone were received as previous therapy, meet all of the following 5 factors:
a.More than 52 weeks after radiotherapy when lung was involved in radiation field
b.No history of grade 2-4 pneumonitis
c.Previous therapy was not terminated due to adverse events, patient refusal
d.Tumor response by previous therapy was not judged as disease progression
e.Total dose of prior CDDP =<210 mg/m2
10)Adequate organ functions:
11)Written informed consent
Key exclusion criteria
1)Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy
2)With active systemic infection disease
3)With active hepatitis B or C
4)With HIV infection
5)With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis
6)Severe psychological illness.
7)With continuous systemic steroid or immune-suppressive drug therapy.
8)Poorly controlled diabetes mellitus or thyroid diseases.
9)Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months
10)With history of hypersensitivity to docetaxel, cisplatin or polysorbate 80-containing formulations
11)Pregnant and/or nursing women or men who wish to have children in future
12)Judged to be unfit to participate in this study by investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Seto |
Organization
The University of Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyoshi |
| Middle name | |
| Last name | Sato |
Organization
The University of Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yasuyoshi_s@hotmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
Tel
03-3815-5411
ethics@m.u-tokyo.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
| 2018 | Year | 04 | Month | 16 | 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
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2018 | Year | 04 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030084
