UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043767
Receipt number R000049943
Scientific Title Nagoya University Esophageal Cancer CRT+/-PDT Prognostic Study
Date of disclosure of the study information 2021/07/06
Last modified on 2021/07/02 17:00:43

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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 or person

Institute

Nagoya University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049943


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name