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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032257
Receipt No. 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 2019/04/20

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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
Email 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
Email yasuyoshi_s@hotmail.com

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
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
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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