UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027589 |
|---|---|
| Receipt number | R000030083 |
| Scientific Title | Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer. |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2023/12/06 13:38:05 |
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Basic information
Public title
Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer.
Acronym
Phase II study of neoadjuvant DCF followed by adjvant S-1 for pN+ forn locally advanced esophageal cancer.
Scientific Title
Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer.
Scientific Title:Acronym
Phase II study of neoadjuvant DCF followed by adjvant S-1 for pN+ forn locally advanced esophageal cancer.
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence free survival(RFS)
Key secondary outcomes
Overall survival(OS)
Response rate(RR)
R0 resction rate
pN positive rate
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
neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer
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 confirmed esophageal squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma
2.Clinical stage II or III (excluding T4) according to the 7th UICC-TNM classification
3.Age over 20 years old.
4.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
5.With or without evaluable lesions according to RECIST ver 1.1.
6.No prior treatment for esophageal cancer, except for (i)-(ii):
(i)The depths of invasion are diagnosed as tumor invades lamina propria mucosa(pT1a-LPM) after a curative endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for esophageal cancer.
(ii)The depths of invasion are diagnosed as tumor invades muscularis mucosa(pT1a-MM) and vascular invasion negative after a previous curative EMR or ESD for esophageal cancer.
7.No prior treatment of chemotherapy, radiotherapy or endocrine therapy against any other malignant tumors, except for hormone therapy for prostate cancer, which has improved before 5 years.
8.Adequate organ functions
9.R0 esophagectomy is expected
10.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 a 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
55
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
Tel
03-3815-5411
askcrc-tantou@umin.org
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
| 2017 | Year | 07 | Month | 01 | 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
98
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030083
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