UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Multicenter Observational Study of Esophageal Preservation Survival in definitive Chemoradiotherapy +/- Photodynamic Therapy for Esophageal Cancer
Acronym	Nagoya University Esophageal Cancer CRT+/-PDT Prognostic Study
Scientific Title	Nagoya University Esophageal Cancer CRT+/-PDT Prognostic Study
Scientific Title:Acronym	NEC2P2 Study
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to collect cases of stage I-IVa esophageal cancer treated with radical (chemo)radiation therapy and to clarify the esophagus preservation survival rate of salvage PDT for patients with local recurrence after radical (chemo)radiation therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	3-year esophageal preservation survival, 5-year esophageal preservation survival of I-IVa esophageal cancer radical (chemo)radiation therapy plus salvage PDT
Key secondary outcomes

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	20 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with Stage I-IVa esophageal cancer diagnosed by imaging or histological diagnosis, who are inoperable or do not wish to undergo surgery. 2) Patients who are scheduled to undergo dCRT of 50.4 Gy or more. 3) Histologically proven esophageal cancer (any of the common histological types) by endoscopic biopsy of the primary esophageal tumor. 4) Patients must have adequate organ function, and if combination chemotherapy is to be administered, either the regimen described in the Guidelines for the Treatment of Esophageal Cancer or fluorouracil plus levofolinate plus oxaliplatin (FOLFOX) is available and will be administered as first-line therapy. 5) Patients must be at least 20 years old at the time of consent. 6) PS (ECOG) is either 0, 1, or 2. 7) Written consent for participation in the study has been obtained from the patient.
Key exclusion criteria	1) Women who are pregnant, may become pregnant (intentionally), or are breastfeeding. Men who wish their partner to become pregnant. 2) Patients with concomitant psychosis or psychiatric symptoms that would make it difficult to participate in the study. 3) Patients with active bacterial and fungal infections (fever of 38 degrees or higher, and bacterial infection documented by imaging or bacteriological examination. (Local infections that do not affect the systemic condition are excluded. 4) Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 5) History of myocardial infarction or unstable angina within 6 months of enrollment. 6) Patients with poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 7) Other patients who are judged by the physician in charge to be unable to tolerate the treatment prescribed in this study.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Naomi Middle name Last name Kakushima
Organization	Nagoya University
Division name	Gastroenterology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
TEL	052-744-2172
Email	nk202004@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Nobuhito Middle name Last name Ito
Organization	Nagoya University
Division name	Gastroenterology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
TEL	052-744-2172
Homepage URL
Email	nito@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	Nagoya University Ethics Committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
Tel	0527442061
Email	ethics@med.nagoya-u.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	2021 Year 07 Month 06 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 25 Day
Date of IRB	2021 Year 06 Month 28 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2028 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observation study

Management information
Registered date	2021 Year 03 Month 28 Day
Last modified on	2021 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049943