UMIN-CTR Clinical Trial

Basic information
Public title	Prognostic effects of the differences in histopathological evaluation between preoperative chemotherapy and preoperative chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma
Acronym	Pathological evaluation and remote results of preoperative chemotherapy versus chemoradiotherapy in advanced esophageal cancer
Scientific Title	Prognostic effects of the differences in histopathological evaluation between preoperative chemotherapy with Docetaxel, CDDP and 5-FU and preoperative chemoradiotherapy in locally advanced esophageal squamous cell carcinoma of Stage III or higher : a retrospective study in a single institution
Scientific Title:Acronym	Histopathological evaluation and treatment results of preoperative DCF and preoperative CRT for advanced esophageal cancer
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The retrospective analyses were performed for two different cohorts of preoperative DCF and preoperative CRT in locally advanced esophageal cancer, and in particular, the results of histopathological effect evaluation from surgical specimens were analyzed for the two cohorts. By doing so, we will consider the ideal form of neoadjuvant therapy, the positioning of surgery, and even better surgical methods.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	To systematically examine the difference in histopathological evaluation between preoperative DCF and preoperative CRT and in the remote results of the cohorts
Key secondary outcomes	To clarify the central role of surgery in the multidisciplinary treatment by presenting the remote results of surgery alone performed without overlapping the patient registration period of preoperative chemotherapy and preoperative CRT cohorts.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	30 years-old <=
Age-upper limit	82 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients with esophageal squamous cell carcinoma in the pretreatment pathological diagnosis. 2.Patients without simultaneous advanced another cancer. 3.Patients It is resistant to surgery in terms of general condition, cardiopulmonary function, and hepato-renal function. 4.Patients to be the candidates of chemotherapy / chemoradiotherapy 5.Patients with UICC7th cT3 or deeper but borderline excision ability , or cT3N1-3. 6.Patients undergoing radical surgery
Key exclusion criteria	1. No pretreatment pathological diagnosis. 2. Simultaneous advanced another cancer. 3. Anxiety about surgical tolerance before treatment. 4. Chemotherapy cannot be performed due to organ function. 5. Although registered in each cohort before the start of preoperative treatment cases in which the actual surgery was not performed due to reasons including side effects of preoperative treatment, tumor regrowth during preoperative treatment and refusal of the patient.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Masao Middle name Last name Hosokawa
Organization	Keiyukai Sapporo Hospital
Division name	Department of Radiation Oncology
Zip code	0030026
Address	Minami 1-1, Hondori-9, Shiroishi-ku, Sapporo
TEL	+8111-863-2101
Email	miyako98kazm@gmail.com

Public contact
Name of contact person	1st name Miyako Middle name Last name Myojin
Organization	Keiyukai Sapporo Hospital
Division name	Department of Radiation Oncology
Zip code	003-0026
Address	Minami 1-1, Hondori-9, Shiroishi-ku, Sapporo
TEL	+81-11-863-2101
Homepage URL
Email	miyako98kazm@gmail.com

Sponsor
Institute	others Keiyukai Sapporo Hospital
Institute
Department

Funding Source
Organization	None
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	Keiyukaisapporo hospital ethics commitee
Address	Minami 1-1, Hondori-9, Shiroishi-ku, Sapporo
Tel	+81-11-863-2101
Email	miyako@keiyukaisapporo.or.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	2021 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	132
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	2011 Year 12 Month 12 Day
Date of IRB	2021 Year 08 Month 20 Day
Anticipated trial start date	2012 Year 01 Month 05 Day
Last follow-up date	2021 Year 05 Month 18 Day
Date of closure to data entry	2021 Year 05 Month 19 Day
Date trial data considered complete	2021 Year 06 Month 15 Day
Date analysis concluded	2021 Year 08 Month 15 Day

Other
Other related information	Observation study about relationship between histopathological evaluation of neoadjuvant therapy and surgical procedures and long-term survival.

Management information
Registered date	2021 Year 08 Month 13 Day
Last modified on	2021 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051438