UMIN-CTR Clinical Trial

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
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
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	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB	2017 Year 10 Month 31 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2020 Year 07 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	2017 Year 07 Month 15 Day
Last modified on	2022 Year 07 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032332