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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028252
Receipt No. R000032332
Scientific Title Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Date of disclosure of the study information 2017/08/01
Last modified on 2018/01/14

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Basic information
Public title Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Acronym Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Scientific Title Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Scientific Title:Acronym Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy and safety of preoperative docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Histopathological response rate
Key secondary outcomes Curative resection rate, response rate in preoperative therapy, histopathological complete response rate, rate of adverse events during preoperative therapy, rate of perioperative complications, rate of late complications, rate of serious adverse events, progression-free survival, and overall survival

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 Docetaxel 70 mg / m2 day 1
Cisplatin 70 mg / m2 day 1
Fluorouracil 750 mg / m2 / day days 1 - 5
Three courses every 3 weeks above
Followed by esophagectomy + D 2 or more lymph node dissection
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.ECOG PS 0-1
2.Endoscopic biopsy of esophageal primary lesion histologically diagnosed as squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma or basal cell carcinoma.
3. Any of the following based on TNM classification (UICC-TNM 7 th edition)
1) cStage IB
2) cStage II
3) cStage III Infiltration into the trachea at the cervical /cervical chest boundary (T4) is eligible. Excluding other T4. So-called borderline-resectable T4 disease, not clearly diagnosed as T4, is eligible.
4) cStage IV with supraclavicular lymph node metastasis and without other distant metastasis.
4. Adequate organ function.
Key exclusion criteria 1) Clear T4 other than invasion of cervical / cervical gastrointestinal tract esophageal cancer
2) Distant metastasis to other than supraclavicular lymph nodes.
3) Esophagogastric junction lesion of which main lesion is located in the stomach rather than the esophagus.
4) Judged not to be eligible by the researchers
Target sample size 28

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Osamu Maeda
Organization Nagoya University Hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya
TEL 052-741-2111
Email maeda-o@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Osamu Maeda
Organization Nagoya University Hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya
TEL 052-741-2111
Homepage URL
Email maeda-o@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 08 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
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 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 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
2017 Year 07 Month 15 Day
Last modified on
2018 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032332

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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